Clinical trial NCT02944656
Conditions: Pain
Keywords: Perioperative pain Outpatient surgery Obstetrics/gynecology Pain management
Sponsor: Emory University
Start date: 2016-12-08; Completion date: 2018-06-26
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.

Detailed description:
Project Summary

Justification for the project

One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. Elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. The management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. Patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year.

Proposed research

This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.

New features

Gabapentin as an adjunct o pain management has proven beneficial in gynecological surgery. Its use in similar surgical settings as an adjunct to pain management regiments has proven to be beneficial. It is generally well tolerated, inexpensive, has minimal side effects, and few contraindications.

Problems anticipated

The high volume at the study clinic will benefit recruitment efforts, however, as the coordination of this study may potentially disrupt clinic flow there will be limits on daily recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to follow-up, most of the outcomes are measured on the same day as the procedure. Further, multiple contact approaches will be employed and a second incentive offered after completion of the postoperative assessment.

Arms: arm 1: This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively. arm 2: This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively.
Interventions: intervention 1: Gabapentin intervention 2: Placebo
Intervention descriptions: intervention 1: Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain. intervention 2: Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion.

Protocol documents:
Prot_SAP_000.pdf: 
Gabapentin as an adjunct to paracervical block for perioperative pain management 
for surgical abortion: a randomized controlled trial 
 
Protocol dated 2/8/16 
 
NCT02944656 
 
 
 
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Gabapentin as an adjunct to paracervical block for perioperative pain management 
for surgical abortion: a randomized controlled trial 
 
 
 
 
 
 
 
 
 
 
 
 
Tiffany Hailstorks MD 
 
Mentors: 
Lisa Haddad MD MPH 
Carrie Cwiak MD MPH 
Emory University 
 
 
 
 
 
 
 
 
 
Date of Submission: 2/8/16 
Email: tiffany.p.hailstorks@emory.edu 
 
 
 
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Table of Contents 
PROJECT SUMMARY .............................................................................................................................................. 5 
1. DESCRIPTION OF THE PROJECT ................................................................................................................... 6 
1.1 RATIONAL AND OBJECTIVES OF THE STUDY ................................................................................................................. 6 
1.1.1 Rationale .......................................................................................................................................................................... 6 
1.1.2 Objectives and hypotheses ........................................................................................................................................ 7 
1.2 PREVIOUS SIMILAR STUDIES ........................................................................................................................................... 8 
1.3 DESIGN AND METHODOLOGY ....................................................................................................................................... 10 
1.3.1 Research design and General Methodology Approach ............................................................................. 10 
1.3.2 Criteria for the selection of subjects ................................................................................................................. 12 
1.3.3 Subject recruitment and allocation .................................................................................................................. 14 
1.3.4 Description of the drugs and devices to be studied.................................................................................... 17 
1.3.5 Admission procedure ............................................................................................................................................... 18 
1.3.6 Follow-up procedure ................................................................................................................................................ 18 
1.3.7 Criteria for discontinuation .................................................................................................................................. 19 
1.3.8 Laboratory and other investigations ............................................................................................................... 21 
1.3.9 Data management .................................................................................................................................................... 21 
1.3.10 Data analysis ............................................................................................................................................................. 21 
1.3.11 Number of subjects and statistical power ................................................................................................... 22 
1.3.12 Study limitations ..................................................................................................................................................... 22 
1.3.13 Duration of the project ......................................................................................................................................... 23 
1.4 PROJECT MANAGEMENT ................................................................................................................................................ 24 
1.5 LINKS IN OTHER PROJECTS ........................................................................................................................................... 24 
1.6 MAIN PROBLEMS ANTICIPATED ................................................................................................................................... 24 
1.7 EXPECTED OUTCOMES OF THE STUDY AND DISSEMINATION OF FINDINGS ........................................................... 24 
1. 8 REFERENCE: ................................................................................................................................................................... 25 
2. ETHICAL CONSIDERATIONS........................................................................................................................ 27 
3. BUDGET ............................................................................................... ERROR! BOOKMARK NOT DEFINED. 
3.1 LINE ITEM BUDGET ............................................................................................ ERROR! BOOKMARK NOT DEFINED. 
3.2 BUDGET JUSTIFICATION .................................................................................... ERROR! BOOKMARK NOT DEFINED. 
Personnel .................................................................................................................... Error! Bookmark not defined. 
Equipment .................................................................................................................. Error! Bookmark not defined. 
Materials and Supplies ......................................................................................... Error! Bookmark not defined. 
Patient Cost ............................................................................................................... Error! Bookmark not defined. 
Travel ........................................................................................................................... Error! Bookmark not defined. 
Other costs.................................................................................................................. Error! Bookmark not defined. 
Contractual costs .................................................................................................... Error! Bookmark not defined. 
4. APPENDICES ....................................................................................... ERROR! BOOKMARK NOT DEFINED. 
APPENDIX ................................................................................................ ERROR! BOOKMARK NOT DEFINED. 
CLINIC RECRUITMENT PROCEDURES ..................................................................... ERROR! BOOKMARK NOT DEFINED. 
ELIGIBILITY CHECKLIST: .......................................................................................... ERROR! BOOKMARK NOT DEFINED. 
EMORY CONSENT ....................................................................................................... ERROR! BOOKMARK NOT DEFINED. 
DRAFT QUESTIONNAIRE .......................................................................................... ERROR! BOOKMARK NOT DEFINED. 
PRE-OP ASSESSMENT ............................................................................................... ERROR! BOOKMARK NOT DEFINED. 
STATE TRAIT ANXIETY INVENTORY [1] ................................................................ ERROR! BOOKMARK NOT DEFINED. 
INTRAOPERATIVE ASSESSMENT ............................................................................. ERROR! BOOKMARK NOT DEFINED. 
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IMMEDIATE POST OP ASSESSMENT  (ON REMOVAL OF SPECULUM) ................. ERROR! BOOKMARK NOT DEFINED. 
10-MINUTE POST OP ASSESSMENT ...................................................................... ERROR! BOOKMARK NOT DEFINED. 
30-MINUTE POST OP ASSESSMENT ...................................................................... ERROR! BOOKMARK NOT DEFINED. 
DISCHARGE ASSESSMENT ........................................................................................ ERROR! BOOKMARK NOT DEFINED. 
24 HOURS POST-PROCEDURE MEASURES .............................................................. ERROR! BOOKMARK NOT DEFINED. 
QUALITY OF RECOVERY SURVEY [3] ...................................................................... ERROR! BOOKMARK NOT DEFINED. 
 
 
 
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Project Summary 
 
Justification for the project 
 
One half of all pregnancies among American women are unintended, with nearly 4 in 10 
ending in pregnancy termination by abortion [22].  Elective abortions are among the most 
common outpatient surgical procedure, with an estimated 46 million performed worldwide 
annually. The management of pain is critical to patient care throughout the abortion 
experience since the vast majority of women will experience pain with the procedure [23].   
Patients are most affected by pain during paracervical block, cervical dilation, suction 
aspiration, and post operatively with uterine cramping [24]. Innovation in pain control and 
reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention 
could impact thousands of women each year.   
Proposed research 
We plan a randomized controlled trial of gabapentin 600 mg compared to placebo given  
1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical 
abortion.  We hypothesize that adding gabapentin to local anesthesia will reduce 
perioperative and post-operative pain associated with surgical abortion.  Additionally, we 
hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of 
pain medication. 
New features 
The use of gabapentin in the setting of abortion has never been evaluated.  Its use in similar 
surgical settings as an adjunct to pain management regiments has proven to be beneficial.  
It is generally well tolerated, inexpensive, has minimal side effects, and few 
contraindications.  
Problems anticipated 
The high volume at our clinic will benefit our recruitment efforts. However the 
coordination of this study may potentially disrupt clinic flow. We will limit our daily 
recruitment to reduce clinic impact. Post-operative follow-up may be challenging, thus to 
reduce the impact of loss to follow-up, most of our outcomes are measured on the same day 
as the procedure. Further, multiple contact approaches will be employed and a second 
incentive offered after completion of the post-operative assessment.  
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1. Description of the Project 
 
1.1 Rational and objectives of the study 
 
1.1.1 Rationale 
 
Surgical abortions in North America are typically performed using local anesthesia, oral 
analgesics, moderate sedation, or a combination of approaches.  A 2009 Cochrane review of 
pain control during abortion concluded that evidence on paracervical block (PCB) alone in 
reducing abortion related pain was limited, while the addition of ibuprofen and naproxen 
can slightly reduce intraoperative and post-operative pain [1] .  Evidence supports the 
benefit of IV sedation (moderate or deep) at reducing intraoperative and post-operative 
pain with abortion.[2] However, IV sedation may not be an option for all women or in all 
clinical settings.  Other recently examined adjuncts to pain control have not proven to be 
beneficial at reducing abortion-related pain [3-5]. 
 
Gabapentin is widely used to treat neuropathic and chronic pain.  The mechanism of 
action may include calcium channel blockade or modulation of nociceptive 
neurotransmitters.  Clinical trials support the use of perioperative pregabalin and 
gabapentin to reduce perioperative and post-operative pain in a variety of clinical settings, 
for both major and minor surgical procedures [6, 7].  While pregabalin has a faster peak 
plasma concentration, gabapentin is a less expensive option with peak concentration 
reached by 2 hours, with substantial evidence to support routine use and safety in reducing 
perioperative pain.   
Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, 
well-tolerated intervention could impact thousands of women each year who undergo 
common outpatient gynecologic procedures.  We propose a novel use of oral gabapentin 
administered in conjunction with local anesthesia via PCB for surgical abortion.  The use of 
gabapentin in the setting of abortion has never been evaluated; however it is used 
routinely and successfully in several similar surgical settings as an adjunct to pain 
management regimens.  It is generally well tolerated and inexpensive, with minimal side 
effects and few contraindications [8].  When used in other gynecologic settings, gabapentin 
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has been shown to improve pain scores, and reduce nausea and vomiting [14,15].  If 
effective, this simple adjunct to current pain regimens could expand options for the 
management of women undergoing surgical abortion.  We believe that the addition of 
gabapentin given prior to the procedure will reduce intraoperative and post-operative 
pain.  Other secondary outcomes such as nausea, vomiting, and anxiety influence a 
woman’s ability to return to her normal baseline level activity and her experience of 
abortion in general.  The addition of gabapentin to current analgesia may provide an option 
to improve a woman’s experience during a surgical abortion.  Gabapentin 600mg was 
selected as a well-tolerated intermediate dosage with benefit proven in prior preoperative 
studies.  Multiple post-operative doses in addition to the pre-operative dose had no 
significant effect on VAS scores at 24 hours, thus favoring single dosage [9].   
 
1.1.2 Objectives and hypotheses 
 
Pain control during and after abortion is a family planning research priority, as identified 
by the Society for Family Planning [10].  Pain management regimens for surgical abortion 
may include: local anesthetic, oral analgesics, moderate sedation, deep sedation, or a 
combination of approaches.  While several recent studies have evaluated supplemental 
medications or therapies intended to reduce abortion-related pain, such as non-steroidal 
anti-inflammatory drugs (NSAIDs), narcotics, anxiolytics, misoprostol, nitrous oxide, or 
music, most have failed to note improved pain scores.  Optimal pain management has yet to 
be established as many women continue to report moderate to severe pain during and after 
an abortion procedure [11]. 
We hypothesize that adding gabapentin pre-operatively to local anesthesia will 
reduce perioperative pain associated with surgical abortion.  Additionally, we hypothesize 
that pre-operative gabapentin will reduce perioperative nausea, vomiting, and anxiety, as 
well as reduce post-operative pain and consumption of pain medication with few adverse 
effects. 
 
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Primary Aim: To evaluate the impact of adjunctive pre-operative gabapentin on 
intraoperative pain scores (at time of evacuation with the start of suction) during surgical 
abortion. 
Secondary Aims: 
 
• To evaluate the impact of pre-operative gabapentin on pain scores post operatively 
(removal of speculum, 10 and 30 minutes after procedure, at time of discharge and 
24 hours after procedure) 
• To evaluate the impact of pre-operative gabapentin on: 
o Perioperative nausea and vomiting 
o Perioperative anxiety 
• To evaluate the impact of pre-operative gabapentin on perioperative medication 
consumption, and pain medication consumption up to 24 hours after the procedure 
• To evaluate safety of gabapentin in this setting (monitor side effects or adverse 
events of gabapentin in this setting) 
1.2 Previous similar studies 
 
There have been multiple studies evaluating pain control during first trimester abortion 
under local anesthesia.  Paracervical block (PCB) alone does not provide optimal pain 
control for all women.  Further, studies evaluating different concentrations of lidocaine or 
different methods of injection did not significantly reduce pain.  Pain with aspiration does 
not differ when comparing 0.5% lidocaine with 1% lidocaine [1].  Aspiration-related or 
post-operative pain does not differ when comparing a four site paracervical block (3,5,7,9 
o’clock positions) to a two site block (4 and 8 o’clock positions) [12].  Non-steroidal anti-
inflammatory drugs (NSAIDS) may be helpful in reducing pain for women receiving an 
abortion with PCB.  Ibuprofen 600 mg given 30 minutes prior to dilation and curettage 
slightly improved intraoperative pain scores with a mean pain difference of 7.8 mm  (on  
100-mm scale)between the ibuprofen and placebo groups, but showed a more significant 
improvement (mean pain difference of 9.3 mm) in pain scores post-operatively [13].  The 
clinically meaningful significance of this difference is questionable.  Naproxen given 1-2 
hours prior to surgery has also been shown to improve pain scores [1].  Although NSAIDs 
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may improve pain with PCB, pain control is still often inadequate and some women may 
not be able to tolerate NSAIDs as they may develop gastrointestinal distress when given.  
Intravenous (IV) moderate sedation has been shown to offer superior perioperative and 
post-operative pain control [1, 14] compared to local anesthesia with PCB; however, 
patients may not be able to receive IV sedation due to the clinical setting, inability to find a 
means of transportation post-operatively, or may find IV sedation unacceptable. 
We propose a novel regimen of oral gabapentin administered in conjunction with 
local anesthesia via PCB for surgical abortion.  Gabapentin is used to treat neuropathic 
pain.  Clinical trials support the use of perioperative gabapentin to reduce perioperative 
and post-surgical pain in a variety of clinical settings [6].  Gabapentin is well-tolerated and 
inexpensive, with mild, if any, side effects [8].   In a systematic review of 22 randomized 
controlled trials (RCT) of multiple surgical procedures including ambulatory nasal surgery, 
orthopedic procedures and laparotomy, a single pre-operative dose of gabapentin 
significantly reduced 24-hour opioid consumption [8].  Of the studies evaluating 
gabapentin use, 13 included a single dose of gabapentin, with doses ranging from 300-
1200mg administered 1-2 hours prior to surgery with results noting a 20-62% reduction in 
opioid consumption within 24 hours after the procedure [8].  In the setting of obstetrics 
and gynecology, evidence supports perioperative gabapentin before hysterectomy to 
reduce pain scores, nausea, and vomiting [9, 15].  Following hysterectomy, the pain 
intensity difference between the control and gabapentin group was greatest in the early 
postoperative period, and decreased after 12 hours.  The dosages ranged from 400mg -
1200mg, and the timing of dosing varied (preoperative dose, followed my multiple dosing 
at interval times identified)[8].  In addition, VAS scores at 24 hours decreased from 9-42.7 
to 2-25.3 mm [9].  This study additionally found the significant reduction in VAS score was 
only noted with pre-operative administration while additional dosing was not associated 
with significant changes when compared to placebo.  Further, postoperative nausea and 
vomiting was also decreased by pre-operative administration of gabapentin. However this 
may be due to decreased opioid consumption [9].  
Preoperative gabapentin prior to cesarean delivery improved pain scores at 24 
hours with less need for post-operative analgesia compared to placebo [15].  A randomized 
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trial in the setting of cesarean delivery showed improved pain scores and decreased pain 
medication requirements with a 600 mg dose of pre-operative gabapentin [15].  In this 
study, patients presenting for scheduled cesarean delivery were randomized to gabapentin 
or lactose placebo given 1 hour preoperatively.  Pain scores with movement were 
evaluated at 24 hours, with the gabapentin group reporting pain scores of 21 mm (95 % CI 
13-28) and the placebo group reporting scores of 41 mm (95% CI 31-50).  Further, the 
gabapentin arm had higher maternal satisfaction scores [15]. 
In an outpatient setting similar to surgical abortion, perioperative gabapentin has 
been shown to decrease post-operative opioid consumption and anxiety for minor 
orthopedic procedures and hemorrhoidectomy [16, 17].  One randomized trial evaluated 
gabapentin 600 mg at 2 hour(s) prior to arthroscopic anterior cruciate ligament (ACL) 
reconstruction [16].  Average pain scores evaluated at 6 and 24 hours following 
reconstructive surgery confirmed that the gabapentin arm experienced significantly lower 
mean pain scores (4.8 at 6 hours on a 10cm scale) in comparison to the placebo group (6.9 
at 6 hours on a 10cm scale) [16]. 
We propose a novel use of oral gabapentin administered in conjunction with 
paracervical block for surgical abortion, and believe that its use in this setting will reduce 
intraoperative and post-operative pain.  Gabapentin 600mg was selected as a well-
tolerated intermediate dosage with benefit proven in prior preoperative studies.  Multiple 
post-operative doses in addition to the pre-operative dose had no significant effect on VAS 
scores at 24 hours, thus favoring single dosage [9].  Gabapentin will be given 1-2 hours 
preoperatively.  A 100-mm pain visual analog scale has been shown to be useful for the 
evaluation of pain in prior pain abortion research [7, 18], with a 30% difference on a 100 
mm-VAS scale, or 13-mm to 22-mm difference, as clinically meaningful [19, 20] [25].   
1.3 Design and Methodology 
 
1.3.1 Research design and General Methodology Approach 
 
This is a randomized double-blind placebo-controlled trial evaluating the impact of 
gabapentin given preoperatively on perioperative pain scores for women receiving a 
surgical abortion.  Randomization will be done using computer generated random 
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numbers.  Allocation concealment will be maintained by identically labeled sealed 
sequentially numbered pill containers.  Gabapentin and placebo will be packaged in 
identical gelatin capsules and sealed by an independent pharmacy. Gabapentin and placebo 
gelatin capsules will be indistinguishable by appearance, thus maintaining double blinding.   
 
Primary study outcomes:  Our primary outcome measure will be pain score using a 100-mm 
visual analog scale (VAS) measured intraoperatively at time of evacuation.  
 
Secondary outcomes:  We will also be measuring pain on the 100-mm VAS preoperatively 
immediately prior to the procedure, at completion of the procedure (removal of the 
speculum), 10 minutes and 30 minutes following the procedure, and at discharge. Nausea 
and vomiting will be assessed during the same time intervals using a 100-mm VAS scale.  
Anxiety prior to the procedure will be measured using the preoperative state trait anxiety 
inventory.  Side effects will be assessed using a checklist prior to discharge. We will also be 
contacting participants on post-operative day 1 to assess pain, nausea, vomiting, side 
effects and general satisfaction with the procedure (on a 5-point scale).  The quantity and 
type of medications used perioperatively and post-operatively, including medications used 
at home in the 24 hours post-operatively, will be abstracted from the clinical record and 
assessed on the phone.  Outcome measures will be collected on a tablet using a web-based 
password-protected relational database (REDCap).  All VAS scale scoring and 
questionnaires will be completed using this database on a research-designated tablet.  
 
Baseline Characteristics and Covariates:   
We will collect baseline demographics, medical history (gravidity, parity, prior abortions 
(medical and surgical), gestational age, drug and alcohol use, psychiatric or sexual assault 
history, medications used at home and given at the clinic preoperatively, and indication for 
procedure (personal/social, fetal, or maternal health).  This information will also be 
obtained using a research-designated tablet. 
Outcome measures and baseline variables are described in table 1. 
 
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1.3.2 Criteria for the selection of subjects 
 
Location:   
This study will take place at Atlanta Women’s 
Center (AWC), a free-standing abortion clinic 
in metro-Atlanta that offers abortion services 
to women up to 23 weeks 6 days gestation.  
This clinic operates 4 days per week 
(Wednesday through Sunday) with a clinical 
volume of 15 to 45 abortions per day.  As 
abortion services are limited in the 
southeastern region of the United States, 
women often travel from other states, 
including Tennessee, Alabama, Florida, 
Mississippi, North Carolina and South Carolina to receive care at this clinic.  Approximately 
4800 women are seen annually at AWC, with 720 women having abortions under local 
anesthesia and 3740 women receiving deep sedation anesthesia. Approximately 3320 
women are 6-12 weeks GA, 800 women are 13-18 weeks and 340 women are over 18 
weeks.  Based on the patient volume, we do not anticipate any difficulty in recruiting 
patients to complete this study within the timeline presented.  Misoprostol for cervical 
preparation is given prior to cases at 10 to 14 weeks per provider preference.  Local 
anesthesia is offered as an option up to 16 weeks, however most cases performed with 
local anesthesia are less than 14 weeks, with the later gestational ages performed with 
deep sedation.   
AWC, where Dr. Haddad is the medical director and the study will be conducted, has 
documented success in participating in and recruiting for several industry sponsored and 
investigator initiated research studies:  a randomized trial of levonorgestrel compared to 
Table 1: Outcome measures and covariates 
Primary outcome 
• 
Pain score validated on a 100mm VAS scale measured 
at time of start of uterine evacuation 
Secondary outcomes: 
• 
Pain on VAS scale: preoperatively, completion of 
procedure (removal of speculum), 10 and 30 min 
following procedure in the recovery room, at time of 
discharge 
• 
Medication use: pain and nausea medication used 
during and after procedure 
• 
Nausea/vomiting: pre op and post op nausea per VAS 
and episodes of vomiting 
• 
Anxiety: preoperative state anxiety inventory 
• 
Side effects 
• 
Postop assessment via phone on POD#1: pain, nausea, 
vomiting, and overall clinic experience 
Covariates of interest: 
• 
Age 
• 
Gravidity, parity, prior abortions 
• 
BMI 
• 
Gestational age 
• 
Preoperative meds 
• 
Current or history of drug abuse 
• 
Current or history of psychiatric disorder 
• 
Indication for procedure 
• 
Expectation of pain 
• 
Pain experience with prior abortion 
• 
Smoking  
 
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ulipristal for emergency contraception (LIFE) study through Washington University in St. 
Louis, and a prospective cohort study of medical abortion through 11 weeks conducted 
with Gynuity.  This study will benefit from the existing research infrastructure and will 
resource share for recruitment and enrollment with another study at this site evaluating 
post-abortion contraception. 
 
Participation selection: 
Women who attend the AWC for an abortion will be approached during their preoperative 
evaluation to determine interest in participating in the study and if so, will be consented for 
the study and then screened for eligibility.  We will enroll a total of 133 women.  A baseline 
survey given after enrollment will collect covariates of interest that may impact a woman’s 
abortion pain experience. 
 
The enrollment of participants is as follows: 
 
Group A: This is the placebo group.  This group will receive local anesthesia per clinic 
protocol PLUS placebo 1-2 hours preoperatively. 
Group B:  This is the gabapentin group.  This group will receive local anesthesia per clinic 
protocol PLUS Gabapentin 600mg 1-2 hours preoperatively. 
 
Gabapentin 600mg was selected as a well-tolerated intermediate dosage with benefit 
proven in prior preoperative studies.  Multiple post-operative doses in addition to the pre-
operative dose had no significant effect on VAS scores at 24 hours, thus favoring single 
dosage [9].   
 
Power Calculation:  
A 100-mm pain visual analog scale has been shown to be useful for the evaluation of pain in 
prior pain abortion research [7, 18], with a 30% difference on a 100 mm-VAS scale, or 13-
mm to 22-mm difference, as clinically meaningful [19, 20] [25].  Assuming a standard 
deviation of 26 mm on the 100-mm VAS scale [7], enrolling 96 women will provide us with 
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an 80% power, using a p-value of 0.05, to detect a 15-mm difference on a 100-mm VAS 
among women presenting for abortion.  The enrollment of 96 women is estimated based on 
a sample size for a t-test.  This sample size is adjusted based on the ARE (asymptotic 
relative efficiency) of the Mann–Whitney U test statistic.  The ARE is based on distribution, 
which is unknown here.  Since the ARE for the Mann-Whitney is never less than 0.864, the 
sample size from the t-test above will be divided by this value.  This creates a sample size of 
111 women.  To account for a potential 20% loss to follow up, the target enrollment goal 
will be increased to 133 total women for participation in this study.   
 
Inclusion and Exclusion Criteria: 
 
Inclusion criteria include: 
- 
Women >=18 years-old 
- 
Presenting for a surgical abortion 
- 
Fluency in English and able to provide informed consent 
- 
Has a driver to take them home 
Exclusion criteria include: 
- 
Allergy, sensitivity or contraindication to gabapentin 
- 
Severe renal disease 
- 
Currently using gabapentin or pregalabin 
- 
Contraindication to outpatient abortion under local anesthesia 
 
Although patients on any chronic pain medications or with pre-existing pain conditions or 
history of alcohol or drug use may have a different metabolism or effect of the drugs, these 
women will not be excluded. Rather, data will be collected on these factors to evaluate the 
impact of these factors on study outcomes. 
1.3.3 Subject recruitment and allocation 
 
All recruitment, consenting, screening, and enrollment questions will be asked by trained 
study staff in a private room. 
 
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Recruitment: 
We will be recruiting until a total of 133 women are randomized.  The proposed research 
will take place at Atlanta Women’s Center (AWC).  Women who attend the AWC for an 
abortion will be approached during their preoperative evaluation.  The flow of steps to 
assess women presenting for abortion occur in the following order: ultrasound for 
gestational age, blood draw to assess hemoglobin and Rh factor, options counseling to 
determine whether surgical abortion is chosen, financial payment, and nurse preoperative 
review.  Trained research staff will approach these women to determine interest in 
participating in the study, consent those interested in participating, and then participants 
will be screened for eligibility.  A standard recruitment script will be employed (Appendix 
A).  We will enroll participants after financial counseling and before nurse preoperative 
review.  Consent will be obtained at time of enrollment.   
 
Screening and consent:   
Individuals who are interested in participating will review the informed consent and 
eligibility screening. We will screen for eligibility using an eligibility checklist (Appendix A).  
Patient contact information will be collected at this time.  Enrollment will occur after 
financial counseling, and consent will be obtained at time of enrollment.  Following 
enrollment, the patient’s medical history will be reviewed by a clinician to ensure study 
eligibility.  Randomization will occur and intervention will be received after enrollment.  
The study drug (intervention or placebo) will be dispensed by the PI, Clinic Director, or 
Clinic Staff Nurse.  Both the Clinic Director and Clinic Staff Nurse are registered nurses with 
required CITI training. 
 
Potential subjects will typically do their 24hr consent over the phone prior to presenting to 
the clinic. Thus, the preoperative evaluation and procedure both occur on the same day. We 
are not approaching any potential subjects for interest in the study until after they have 
selected local anesthesia and paid for their procedure. 
 
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The abortion providers are not involved in the discussion with the patient regarding 
“timing, method, or procedures used to terminate a pregnancy”. This is a discussion that 
the clinic staff has with the patient after ultrasound evaluation (to confirm gestational age) 
and financial counseling. The patient also goes through options counseling with clinic staff 
(not the abortion provider) during which the different types of procedures are discussed 
(medical vs surgical procedure based on gestational age). The study team will only begin 
interaction with the potential subject/patient once they’ve selected local anesthesia and 
paid for their procedure. The Investigators will only be involved after this point. 
Investigator involvement may include consenting the subject, administering the study drug, 
performing the procedure, and other study related activities such as administering the 
questionnaire. There is one abortion provider per day at Atlanta Women’s Clinic and if an 
investigator is the provider for that day, she will not participate in any other study-related 
activities. 
 
The person obtaining the consent will be a member of the study team.  This person will 
have no prior contact with the study patient.  This person will not be scheduling the 
appointment, discussing options counseling, advising about the procedural options, or 
performing ultrasound or other laboratory work-up for the participant prior to the 
procedure.  There is a clear separation between study staff and clinic staff prior to the 
enrollment of participants into the study, 
 
Randomization, Allocation Method and Blinding: 
Women who enroll and meet study inclusion criteria will be eligible for participation.  
Randomization will be done using computer-generated random numbers 
(randomization.com) in variable blocks of 4 and 6.   Allocation concealment will be 
maintained by identically labeled sealed sequentially numbered opaque pill containers. 
Gabapentin and placebo tablets will be indistinguishable by appearance (both gelatin 
capsules), thus maintaining blinding for participants and assessors. To maintain double 
blinding for both investigators and participants, an individual not associated with study 
conduct will create the randomization sequence and allocation containers. The study drug 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


and placebo will be obtained through the Duke Investigational Drug Service that will 
vacuum seal the containers prior to shipping to the clinic. The randomization assignments 
will only be revealed at the point of data analysis or if an interim assessment is needed. 
1.3.4 Description of the drugs and devices to be studied 
 
Gabapentin was originally approved by the U.S. Food and Drug Administration (FDA) in 
December 1993, for use as an adjuvant (effective when added to other antiseizure drugs) 
medication to control partial seizures in adults; that indication was extended to children in 
2000 [21], and later approved for treating postherpetic neuralgia.  In December 2004, the 
FDA granted final approval to a generic equivalent to Neurontin made by the Israeli firm 
Teva.  It was originally synthesized to mimic the chemical structure of the neurotransmitter 
GABA. The mode of action of gabapentin is believed to be through its binding to the alpha 2 
delta subunit of the DRN voltage-dependent calcium channels.  This causes decreased entry 
of calcium into the nerve endings, resulting in decreased release of nociceptive 
neurotransmitter (glutamate, substance p, noradrenaline).  Other proposed mechanisms of 
action include the binding to NMDA receptors, sodium channel receptors, monoaminergic 
receptors, and opioid receptors. 
Overall, gabapentin is a safe drug. The most common side effects of its use include: 
dizziness, somnolence, fatigue, ataxia, peripheral edema, nystagmus, nausea and vomiting, 
asthenia, headache, weight gain, and amblyopia.  Most of the side effects are associated 
with chronic usage.  Other extremely rare side effects include: DRESS (drug reaction with 
eosinophilia and systemic symptoms), multi-organ hypersensitivity, withdrawal seizures 
(if given for epilepsy), suicidal behavior and ideation, neuropsychiatric reactions in 
pediatric patients (3-12 years of age), and sudden death. 
Drug Interactions are rare and mild. Maalox or other aluminum or magnesium 
hydroxides decreases bioavailability of gabapentin by 20% if given at same time.  
Additionally, when used with hydrocodone or morphine, gabapentin may decrease the 
AUC.  Abuse and withdrawal potential is low.  The drug is almost entirely metabolized 
through renal metabolism, where it is eliminated unchanged in the urine, thus dosage 
adjustments are needed for patients with renal impairment.  The half-life for the 
medication is 5-7 hours with a 2 hour time to peak plasma concentration. 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


 
1.3.5 Admission procedure 
 
After financial clearance, all participants who have opted for a surgical abortion with local 
anesthesia will be approached for interest in the study.  A study interest card will be placed 
on their medical chart, and the participant will be accompanied by the financial counselor 
and taken to the designated research room.  This designated research room is a private 
room located in AWC.  The study team will then review the recruitment script with the 
patient.  If the patient is interested in the study, then a member of the study team will 
consent the participant.  Following consent and enrollment into the study, the participant 
will be taken to the clinical nurse.  The nurse will review the participant’s chart to ensure 
eligibility for surgical abortion and gabapentin administration.  The participant will then 
receive the study drug or placebo.  Following administration of the drug, the participant 
will return to the designated research room.  The study staff will review the baseline 
questionnaire that includes demographic questions.  Following completion of the 
questionnaire, the participant will continue to wait in the designated research room or 
preoperative area.  One hour after the administration of the drug or placebo, the 
participant’s chart will be placed back into rotation for surgical procedures.  The study 
team will accompany the participant to the clinical lounge where they will gown and 
prepare for the procedure.  The participant will then undergo the procedure in order of 
chart placement.  Prior to initiating the abortion procedure, study staff will administer the 
preoperative questions.  Staff will administer the intraoperative questions at the time of 
evacuation during the uterine aspiration, and at time of removal of the speculum at the end 
of the procedure.  Immediately following the procedure, the study staff will follow the 
participant to the recovery room to complete the remaining questions assessed at 10 
minutes, 30 minutes and at discharge. Per clinic protocol, patients remain in the recovery 
room for approximately 30-60 minutes after surgical abortion with local anesthesia. When 
the discharge questions are complete, the participant will receive a $30 gift card and be 
reminded to expect a follow-up call the following day (post operative day #1). 
1.3.6 Follow-up procedure 
 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


On the day following the procedure (approximately 24 hours after the abortion), study staff 
will contact the participant to complete the follow-up questions.  The participant will be 
contacted via email, text communication and telephone.  Upon completion of the questions, 
an additional $20 will be added to the original gift card.  
 
Withdrawals, losses, and deviations: 
Randomization to the study method will occur after completion of all intake forms and 
consent, immediately before the pill is to be taken, thus reducing the possibility of 
withdrawal after randomization. Any significant medical history will be reviewed prior to 
enrollment with a clinician at the clinic to ensure study eligibility.  Primary outcome 
measures and most secondary outcome measures will be assessed immediately before, 
during or after the abortion procedure, thus any loss to follow-up will be limited to those 
who consent to, but change their mind while waiting for their procedure. Based on current 
clinical practice at this clinic, withdrawal after consent is extremely rare. Our secondary 
outcomes assessed post-operatively after discharge will be collected via telephone. We will 
maximize completion of these assessments through the following steps: participants will be 
told beforehand about the telephone contact following the procedure, a cellular telephone 
number will be collected and tested at the clinic, a secondary phone number and email will be 
collected as a backup, participants will be given a contact number for the study coordinator 
should they have any challenges with receiving phone calls, and participants will receive an 
additional $20 sent to their gift-card following the completion of their phone assessment. 
Subjects will be considered lost-to-follow-up if they have not responded to the follow up survey 
within 48 hours after their procedure. As we anticipate some loss to follow-up for our secondary 
outcome on post-operative day 1, we have adjusted our study enrollment to provide some 
accommodation for 20% loss to follow-up. 
1.3.7 Criteria for discontinuation 
 
An adverse event (AE) is defined as any health-related reaction, effect, toxicity or abnormal 
laboratory result that a study participant experiences during the course of the study, 
irrespective of relationship to the study intervention.  This includes changes in a 
participant’s condition that have or could have a deleterious effect on a participant’s health 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


or well-being.  A serious adverse event (SAE) is defined as any experience that is fatal or 
life threatening, requires in-patient hospitalization or prolongation of an existing 
hospitalization, or results in a persistent or significant disability or incapacity. 
 
This study uses an additional medication for pain control in the setting of outpatient 
abortion.  These activities are not anticipated to be associated with any deleterious impact 
on participants’ health or well-being beyond the risks associated with the abortion 
procedure. AEs will be managed according to good clinical practice and the judgment of the 
on-site physician. All clinical and laboratory AEs will be followed-up closely by study staff. 
Any SAEs will be expeditiously reported to the principal investigators, via a designated SAE 
form.  Notification and submission of SAE forms should occur within 48 hours of the site 
awareness of the SAE. The PI will then make the final independent judgment as to the 
severity, relatedness, and anticipated or unanticipated nature of the SAE and finalize the 
Human Subjects Adverse Event Report Form.  If the event is determined to be serious, 
unanticipated, and the relationship is anything other than probably or definitely not 
related, then the PI will report the event within 48 hours and submit the required forms to 
the IRB at Emory.  Thus, all anticipated SAEs that are at least possibly related to study 
intervention and all deaths that are at least possibly related to study intervention will be 
submitted to Emory IRB. 
 
The study may be discontinued at any time by IRB at a participating institution or 
the Office for Human Research Protection.  One of the co-investigators (TH) will review any 
adverse event and periodically review side effects to see if there are an increased number 
of events than anticipated by routine clinical care.  If any suspicion for increased risk exists, 
study allocation may be revealed for a preliminary analysis and if related to the study 
intervention, the study could be prematurely ended. 
 
Data Monitoring Committee/Study Termination:   
A Data Monitoring Committee (DMC) will be created to perform regular and timely review 
of data in order to identify early, significant benefit or harm for patients while the trial is in 
progress.  On a regular basis (frequency as to be determined by the DMC based on the 
enrollment rate and potential risk to subjects), non-identified safety data will be 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


communicated to the DMC who will then meet to review the data.  The DMC will be 
composed of three faculty members within the Emory University Department of 
Gynecology and Obstetrics. Individuals who are investigators or co-investigators cannot be 
members.  No member of the research study team will be on the committee.  Members 
must have no financial, scientific, or other conflicts of interest with the study.  All 
investigators understand that the DMC serves as additional human subject’s protection, but 
does not supplant reporting of significant adverse events to the Emory IRB. The DMC may 
devise its own stopping rules, and if there are significant numbers of adverse events, the 
DMC will recommend continuation, modification, or termination of the study after each 
meeting.  This recommendation will be communicated to the principal investigator who is 
responsible for reviewing the recommendation and forwarding it to the IRB.  . 
 
1.3.8 Laboratory and other investigations 
 
Examinations will be performed prior to the surgical abortion that are in accordance with 
the standard of care. No additional laboratory studies will be performed for the clinical 
trial. 
1.3.9 Data management 
 
Prior to study initiation, a database will be developed using a web-based password-
protected relational database (REDCap).  All data will be collected electronically into the 
database on tablets.  All consent documents will be filed in a locked cabinet and stored for 
future reference.  Data will be collected on research-designated tablets. 
1.3.10 Data analysis 
 
We will compare groups on the primary continuous outcome measure (pain score on  
100-mm point VAS) using T-tests and Mann-Whitney U test.  Chi-square and T-tests will be 
used to evaluate secondary outcomes for categorical and continuous variables, 
respectively. Baseline characteristics will be evaluated for potential interaction or 
confounding with primary and secondary outcomes.  
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All available data from completed questions will be used for analysis, including 
partially completed surveys.  Participants may request that their data not be used for 
analysis if a request is received prior to analysis as mentioned in the consent form. A 
statistician will be consulted to assist with the analysis as needed. 
1.3.11 Number of subjects and statistical power 
 
We will enroll a total of 133 women. This number was determined to give us sufficient 
power to detect a 15-mm difference on the 100-mm VAS. A 100-mm pain visual analog 
scale has been shown to be useful for the evaluation of pain in prior pain abortion research 
[7, 18], with a 30% difference on a 100 mm-VAS scale, or 13-mm to 22-mm difference, as 
clinically meaningful [19, 20] [25].  Assuming a standard deviation of 26 mm on the 100-
mm VAS scale [7] based on the literature, a total of 96 participants will provide us with an 
80% power, using a p-value of 0.05, to detect a 15-mm difference among women 
presenting for abortion.  The enrollment of 96 women is estimated based on a sample size 
for a t-test.  This sample size is adjusted based on the ARE (asymptotic relative efficiency) 
of the Mann–Whitney U test statistic.  The ARE is based on distribution, which is unknown 
here.  Since the ARE for the Mann-Whitney is never less than 0.864, the sample size from 
the t-test above will be divided by this value.  This creates a sample size of 111 women.  To 
account for a potential 20% loss to follow up, the target enrollment goal will be increased 
to 133 total women for participation in this study.  Therefore we determined that 133 
women would need to be enrolled.  
1.3.12 Study limitations 
 
Strengths of this study include the location site and its ability to recruit the sample 
population, as well as the previous research being done at AWC.  Pain perception is 
complex and composed of a multitude of elements.  This study will also attempt to allow for 
the comprehensive evaluation of pain and identify behavioral factors that influence one’s 
perception of pain throughout the abortion. 
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Limitations of the study include gestational age limits.  Local anesthesia is only 
offered to patients up to 14-15 weeks so this will not allow for the evaluation of later 
gestational ages in which patient’s may benefit from this adjunct medication.   
Gabapentin is low-cost and effective in perioperative settings, and may be an 
effective adjunctive therapy for surgical abortion.  Future direction may involve a 
prospective multi-site analysis (PMA).   PMA methodology will evaluate the potential effect 
of adding gabapentin to different pain control regimens and among different patient 
populations, maximizing external validity. Further, we aim to leverage the developed PMA 
infrastructure to apply for future large research studies in abortion care, providing an 
innovative and feasible approach for developing generalizable research and to target low 
prevalent groups. 
1.3.13 Duration of the project 
 
We plan on obtaining Emory IRB approval, hiring staff and completing clinic and study staff 
training by Spring 2016.   We are in contact with a compounding drug lab and will obtain 
the study drug by Spring 2016.  Study recruitment and data collection is projected to begin 
in early 2016.  The expected length of data collection is 9-12 months.  We will complete 
data analysis and drafting of the manuscript during the last 6 months of the study period.  
Refer to table 2 for additional details. 
 
Table 2: Project timeline 
 
2016 
2017 
 
 
 
 
Study Activity 
September 
October 
November 
December 
January 
February 
March 
April 
May 
June 
Hire and train staff 
 
 
 
 
 
 
 
 
 
 
Compounding study drug, randomization and 
allocation packaging, distribution 
 
 
 
 
 
 
 
 
 
 
Database development 
 
 
 
 
 
 
 
 
 
 
 
Study recruitment and data collection 
 
 
 
 
 
 
 
 
 
 
Site data analysis and manuscript preparation 
 
 
 
 
 
 
 
 
 
 
 
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1.4 Project management 
 
At Emory, the principal investigator is Dr. Tiffany Hailstorks with Dr. Lisa Haddad. 
Dr. Carrie Cwiak, as faculty mentor. Drs. Hailstorks and Haddad will be the primary 
contacts and responsible parties for the study. 
1.5 Links in other projects 
 
This project is not linked with any existing project.  
1.6 Main problems anticipated 
 
This study aims to recruit 133 women into a randomized controlled trial in an outpatient 
abortion setting.  Given the patient volume at this clinic, coordination of the study may be 
challenging, however we anticipate that the patient volume is a factor that will increase the 
success in reaching recruitment targets quickly.  To ensure that patient flow is not 
interrupted, we will have study staff dedicated to the study activities including consent and 
data collection, thus eliminating any dependence upon current clinical staff for study 
operation.  We also anticipate that follow-up on post-operative day one may be challenging.  
To reduce the impact of loss to follow-up, our primary impact measure and most of our 
secondary measures are measured on the same day as the procedure.  Further, to maximize 
retention, we will test a phone number at the time of enrollment, collect secondary contact 
information, give the patient a contact number for the study coordinator should they have 
difficulty receiving a call, and provide reimbursement for completion via transferring funds 
to a gift-card following completion of the follow-up questionnaire. 
1.7 Expected outcomes of the study and dissemination of findings 
 
The benefits of this research directly extend to potential improvements in the pain 
management procedures provided at the facility.  Moreover, the results could potentially 
impact individuals globally as we aim to better address pain management in the setting of 
outpatient abortion.  Continued efforts are needed to optimize pain control during surgical 
abortion.  Gabapentin is a safe and inexpensive medication that has been employed as an 
adjunct to anesthesia with significant reductions in perioperative pain and nausea.  We aim 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


to explore this novel medication as an adjunct to local anesthesia where other 
interventions have been less successful in improving pain scores. 
 
1. 8 Reference: 
 
1. 
Renner, R.M., J Jensen, M Nichols, A Edelman, Pain control in first trimester surgical 
abortion (Review). Cochrane Database of Systemic Reviews 2009 2009(2). 
2. 
Allen RH, F.G., Lifford KL, Lasic M, Goldberg AB., Oral compared with intravenous 
sedation for first-trimester surgical abortion: a randomized controlled trial. Obstet 
Gynecol, February 2009. 113: p. 276-83. 
3. 
Jackson, E. and N. Kapp, Pain control in first-trimester and second-trimester medical 
termination of pregnancy: a systematic review. Contraception, 2011. 83(2): p. 116-
26. 
4. 
Braaten, K.P., et al., Intramuscular ketorolac versus oral ibuprofen for pain relief in 
first-trimester surgical abortion: a randomized clinical trial. Contraception, 2014. 
89(2): p. 116-21. 
5. 
Chor, J., et al., Doula support during first-trimester surgical abortion: a randomized 
controlled trial. Am J Obstet Gynecol, 2015. 212(1): p. 45 e1-6. 
6. 
Schmidt PC, R.G., Mackey SC, Carroll IR, Perioperative gabapentinoids: choice of 
agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 119. 
7. 
Clarke, H., et al., The prevention of chronic postsurgical pain using gabapentin and 
pregabalin: a combined systematic review and meta-analysis. Anesth Analg, 2012. 
115(2): p. 428-42. 
8. 
Tiippana, E.M., et al., Do surgical patients benefit from perioperative 
gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg, 
2007. 104(6): p. 1545-56, table of contents. 
9. 
Higginbotham, S.L., The SFP research priority setting process. Contraception, 2015. 
92(4): p. 282-8. 
10. 
Raymond, E.G., et al., Prophylactic compared with therapeutic ibuprofen analgesia in 
first-trimester medical abortion: a randomized controlled trial. Obstet Gynecol, 2013. 
122(3): p. 558-64. 
11. 
Glantz JC, S.S., Comparison of paracervical block techniques during first trimester 
pregnancy termination. International Journal of Gynecology and Obstetrics, 2001. 
72: p. 171-78. 
12. 
Wiebe ER, R.M., Pain control in abortion. International Journal of Gynecology and 
Obstetrics, 1995. 50: p. 41-46. 
13. 
Nancy, W., Reducing distress during abortion: a test of sensory information. Journal of 
Advanced Nursing, 1992. 17: p. 1050-56. 
14. 
Alayed, N., et al., Preemptive use of gabapentin in abdominal hysterectomy: a 
systematic review and meta-analysis. Obstet Gynecol, 2014. 123(6): p. 1221-9. 
15. 
Moore, A., et al., Gabapentin improves postcesarean delivery pain management: a 
randomized, placebo-controlled trial. Anesth Analg, 2011. 112(1): p. 167-73. 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


16. 
Mardani-Kivi, M., Is Gabapentin Effective on Pain Management after Arthroscopic 
Anterior Cruciate Ligament Recontruction? A Triple Blinded Randomized Controlled 
Trial. Archive of Bone and Joint Surgery, 2013. 1: p. 18-22. 
17. 
Poylin, V., et al., Gabapentin significantly decreases posthemorrhoidectomy pain: a 
prospective study. Int J Colorectal Dis, 2014. 29(12): p. 1565-9. 
18. 
Renner, R.M., et al., Paracervical block for pain control in first-trimester surgical 
abortion: a randomized controlled trial. Obstet Gynecol, 2012. 119(5): p. 1030-7. 
19. 
Jensen, M., Interpretation of visual analog scale ratings and change scores: a 
reanalysis of two clinical trials of postoperative pain. The Journal of Pain, 2003. 4(7): 
p. 407-414. 
20. 
Todd, K., Clinical Significance of Reported Changes in Pain Severity. Annals of 
Emergency Medicine, 1996. 24: p. 485-89. 
21. 
Mack, A., Examination of the Evidence for Off-Label Use of Gabapentin. Journal of 
Managed Care Pharmacy, 2003. 9: p. 559-568. 
22.        Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United 
States, 2001-2008. Am J Public Health. 2014; 104 Suppl 1:S43-8. 
23.        Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester 
surgical abortion: a systematic review of randomized controlled trials. 
Contraception. 2010; 81:372-88. 
24.       Meckstroth KR. Analgesia/Pain Management in First Trimester surgical Abortion. 
Clincial Obstetrics and Gynecology. 2009; 52:160-70. 
25.       Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 
2001;94:131-2. 
 
 
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2. Ethical Considerations 
 
The study will not commence until the study protocol has been reviewed and approved by 
the Emory University Institutional Review Board (IRB). 
 
Risk of medication: Gabapentin has been used in several other clinical settings and is 
associated with few side effects, thus the risks associated with its use as an adjunct to 
abortion perioperative pain regimens are minimal.  As this is a low-cost intervention that 
has promise for improving pain, the potential for risk is balanced by the potential benefit.  
Side effects and adverse effects will be carefully tracked and monitored during the study.  
Documented side effects of gabapentin include: dizziness, somnolence, fatigue, ataxia, 
peripheral edema, nystagmus, nausea and vomiting, asthenia, headache, weight gain, and 
amblyopia.  Most side effects are associated with chronic usage.  Other rare side effects 
include: DRESS (drug reaction with eosinophilia and systemic symptoms), multi-organ 
hypersensitivity, withdrawal seizures (if given for epilepsy), suicidal behavior and ideation, 
neuropsychiatric reactions in pediatric patients (3-12 years of age), and sudden death. 
 
Sensitive information: The risks involved in study participation are those related to 
providing personal information about sensitive topics.  Participants’ privacy and the 
confidentiality of data will be protected through training of study staff, conducting all 
interviews and procedures in private, storing study materials in a locked room, and 
securing computer files that include identifiers.  Only the study identification number will 
identify participant research records.  Linkages between the ID number and participants’ 
identifying information will be maintained in a computer database that is password 
protected and only accessible to study staff. These linkages will be destroyed 7 years after 
completion of study activities.  We will ensure that study staff is thoroughly trained to not 
disclose any information about the study or the participant’s attendance at the clinic to any 
individual other than the study participant.  Breaches of confidentiality are possible, 
though safeguards are in place to protect the confidentiality of participants.  Thus, the 
potential for experiencing an adverse event is minimal. 
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Gabapentin: 
Gabapentin is indicated for the management of postherpetic neuralgia in adults, as 
adjunctive therapy in the treatment of seizure disorder, and for chronic pain management.  
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the 
drug or its ingredients.  When gabapentin is taken for chronic use, side effects are noted. 
Drug reaction with eosinophilia and systemic symptoms, also know at multiorgan 
hypersensitivity, has occurred with gabapentin.  These reactions can be fatal or life 
threatening.  Typical symptoms include but are not limited to fever, rash, 
lymphadenopathy, hepatitis, nephritis, hematological abnormalities, myocarditis, or 
myositis.  In the presence of signs or symptoms, prompt evaluation and discontinuation of 
gabapentin is warranted.  Although rare, gabapentin can cause anaphylaxis and 
angioedema after the first dose or any time during treatment.  The patient should be 
instructed to discontinue the medication and seek immediate medical attention. 
 
During the controlled epilepsy trials in patients older than 12 years of age, the 
patients who received gabapentin (up to 1800mg daily) reported greater rates of 
somnolence (19%), dizziness (7%) and ataxia (6%) when compared to the placebo group.  
During the controlled trials in patients with postherpetic neuralgia taking doses of 
gabapentin up to 3600mg, patients reported increased somnolence (21% of the gabapentin 
arm vs. 5% of the placebo arm), and dizziness (28% of the gabapentin arm vs. 8% of the 
placebo arm).  Patients should be carefully observed for signs of central nervous system 
depression, especially when gabapentin is used with other drugs with sedative properties.  
 
Antiepileptic drugs (AEDs), including gabapentin, increase the risk of suicidal 
thoughts or behavior in patients taking these drugs for any indication.  Patients should be 
monitored for the emergence or worsening depression, suicidal thoughts or behavior, 
and/or unusual changes in mood or behavior.  Pooled analysis showed that patient 
randomized to one of the AEDs had approximately twice the risk of suicidal thinking or 
behavior compared to patients randomized to placebo.  It should be noted that these trials 
had a median treatment duration of 12 weeks. 
 
During the premarketing developing of gabapentin, there were 8 sudden or 
unexplained deaths that were recorded among a cohort of 2203 epilepsy patients treated 
Fellowship in Family Planning Research Proposal Outline
 
 
 
 
 
 


with gabapentin.  This rate exceeds that expected in a healthy population that is matched 
for age and sex.  This rate falls within the range of estimates for the incidence of sudden 
unexplained deaths in patients with epilepsy not receiving gabapentin. 
 
Below is a table that outlines adverse reactions that occurred in at least 1% of gabapentin 
treated patients with postherpatic neuralgia participating in placebo-controlled trials. 
 
Adverse reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia 
Gabapentin ( N=336, %) 
Placebo (N=227, %) 
Body as a whole 
Asthenia 
6 
5 
Infection 
5 
4 
Accidental injury 
3 
1 
Digestive system 
Diarrhea 
6 
3 
Dry mouth 
5 
1 
Constipation 
4 
2 
Nausea 
4 
3 
Vomiting 
3 
2 
Metabolic and nutritional disorders 
Peripheral edema 
8 
2 
Weight gain 
2 
0 
Hyperglycemia 
1 
0 
Nervous system 
 
 
Dizziness 
28 
8 
Somnolence 
21 
5 
Ataxia 
3 
0 
Abnormal thinking 
3 
0 
Abnormal gait 
2 
0 
Incoordination 
2 
0 
Respiratory 
Pharyngitis 
1 
0 
Special senses 
Amblyopia 
3 
1 
Conjunctivitis 
1 
0 
Diplopia 
1 
0 
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Otitis media 
1 
0 
Below is a table that outlines adverse reactions that occurred in at least 1% of gabapentin- 
treated patients over the age of 12 who participated in placebo-controlled trials on 
epilepsy. 
Adverse reactions in Pooled Placebo-Controlled Trials in Epilepsy patients over age 12 
Gabapentin ( N=543, %) 
Placebo (N=378, %) 
Body as a whole 
Fatigue 
11 
5 
Increased weight 
3 
2 
Back pain 
2 
1 
Peripheral edema 
2 
1 
Cardiovascular 
Vasodilation 
1 
0 
Digestive system 
Dyspepsia 
2 
1 
Dry mouth and throat 
2 
1 
Constipation 
2 
1 
Dental abnormalities 
2 
0 
Nervous system 
Dizziness 
17 
7 
Somnolence 
19 
9 
Nystagmus 
8 
4 
Ataxia 
13 
6 
Tremor 
7 
3 
Dysarthria 
2 
1 
Amnesia 
2 
0 
Depression 
2 
1 
Abnormal thinking 
2 
1 
Abnormal coordination 
1 
0 
Respiratory 
Pharyngitis 
1 
0 
Coughing 
2 
1 
Skin and appendages 
Abrasions 
1 
0 
Urogenital system 
Impotence 
2 
1 
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Special senses 
Amblyopia 
4 
1 
Diplopia 
6 
2 
 
Data presented here is directly from FDA prescribing information.  The gabapentin drug 
information in this section is from the FDA website.  Our study will only administer a one-
time dose of gabapentin, and therefore we do not anticipate the side effects listed that are 
more likely associated with chronic use. 
Reference: 
http://www.drugs.com/pro/gabapentin.html#S5.4 
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