Clinical trial NCT05494385
Conditions: Postoperative Pain
Sponsor: Indiana University
Start date: 2021-07-27; Completion date: 2023-07-05
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Preoperative Gabapentin/Postoperative Placebo intervention 2: Preoperative Gabapentin/Postoperative Gabapentin
Intervention descriptions: intervention 1: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain. intervention 2: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.

Protocol documents:
Prot_SAP_001.pdf: 
IRB#: 10970 
NCT05494385 
Date 03/23/2021 
 
 
Page 1 of 13 
 
Effect of Perioperative Gabapentin on 
Postoperative Opioid Requirements 
 
Michael Heit, MD PhD 
Fellowship Director, Female Pelvic Medicine and Reconstructive Surgery 
Volunteer Clinical Associate Professor of Obstetrics & Gynecology 
Indiana University School of Medicine 
Physician & Surgeon, Indiana University Health Urogynecology 
11725 N Illinois St, Ste 140 
Carmel, IN 46032 
 
 
 
 
 
Co-Investigators and affiliations: 
Anna Guanzon, MD 
Female Pelvic Medicine and Reconstructive Surgery 
Fellow, Indiana University School of Medicine 
 
Douglass Hale, MD 
Female Pelvic Medicine and Reconstructive Surgery 
Volunteer Clinical Professor 
Indiana University School of Medicine 
Physician & Surgeon, Indiana University Health Urogynecology 
 
Jennifer Hamner, DO, DPT 
Female Pelvic Medicine and Reconstructive Surgery 
Assistant Professor of Obstetrics & Gynecology 
Indiana University School of Medicine 
Physician & Surgeon, Indiana University Health Urogynecology 
 
Alex Hubb, MD 
Female Pelvic Medicine and Reconstructive Surgery 
Fellow, Indiana University School of Medicine 
 
Andrew Doering, MD 
Female Pelvic Medicine and Reconstructive Surgery 
Fellow, Indiana University School of Medicine 
 
 
 
Support Provided by: 
N/A 
 
 


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Table of Contents: 
 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
2.3 
Tertiary/Exploratory/Correlative Objectives 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
3.2 
Secondary Outcome Measures 
3.3 
Tertiary/ Exploratory/ Correlative Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
5.0 
Study Design 
6.0 
Enrollment/Randomization 
7.0 
Study Procedures 
8.0 
Study Calendar 
9.0 
Reportable Events 
10.0 Data Safety Monitoring 
11.0 Study Withdrawal/Discontinuation 
12.0 Statistical Considerations 
13.0 Data Management 
14.0 Privacy/Confidentiality Issues 
15.0 Follow-up and Record Retention 
16.0 References 
17.0 Appendix 
 


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Abbreviations 
 
ERAS 
Enhanced Recovery After Surgery 
ACOG American College of Obstetricians and Gynecologists 
FDA 
Food and Drug Administration 
AAGL 
American Association of Gynecologic Laparoscopists 
ASA 
American Society of Anesthesiologists 
CMP 
Comprehensive metabolic profile 
PACU 
Post-anesthesia care unit 
PO 
By mouth 
 
1.0 
Background & Rationale 
 
A multimodal analgesic approach is the mainstay of controlling postoperative pain and reducing 
opioid consumption in Enhanced Recovery After Surgery (ERAS) protocols [ACOG 2018]. This 
includes scheduled acetaminophen and non-steroidal anti-inflammatory drugs, in addition to 
neuromodulators such as gabapentin. Perioperative gabapentin has been proven to reduce 
inpatient opioid use after hysterectomy. This is desirable given the ongoing opioid epidemic and 
risks associated with opioid use, including opioid tolerance, dependence, constipation, and 
dizziness. However, the ideal dose and timing of administration of gabapentin has not been 
defined. This is reflected by differing recommendations regarding gabapentin use in ERAS 
protocols from the American College of Obstetrics and Gynecology, ERAS Society guidelines for 
gynecologic/oncology, and the Association of Gynecologic Laparoscopists (AAGL). 
 
The ACOG practice bulletin on ERAS protocols recommends consideration of gabapentin 600 mg 
preoperatively and scheduled gabapentin postoperatively [ACOG 2018]. ERAS Society guidelines 
for perioperative care in gynecologic/oncology surgery recommend but do not specify the dose 
or timing of routine preoperative administration of gabapentin in addition to consideration for 
postoperative use [Nelson 2019]. In contrast, AAGL released a task force in August 2020 
recommending against the use of gabapentin in ERAS protocols, citing the FDA safety concerns 
[Stone 2021]. The FDA safety communication published December 2019 warned that serious 
breathing difficulties may occur in patients using gabapentin concurrently with opioid pain 
medications [FDA 2019]. 
 
However, as stated above, use of perioperative gabapentin decreases inpatient opioid use 
following gynecologic procedures. While efforts to reduce use of opioids should be maximized, 
judicious use of gabapentin is warranted given changes in its safety profile. Determining if 
preoperative gabapentin use alone is noninferior to preoperative and postoperative gabapentin 
in reducing opioid use furthers this goal. 
 
The purpose of this study is to determine if preoperative gabapentin is noninferior to 
preoperative and postoperative gabapentin for pain control in patients undergoing surgery for 
pelvic organ prolapse. 
 
 
2.0 
Objective(s) 
2.1 
Primary Objective 


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The primary objective is to determine if preoperative gabapentin alone is noninferior to 
preoperative and postoperative gabapentin with respect to percentage of patients 
requiring opioid prescription at discharge. 
 
2.2 
Secondary Objective 
The secondary objectives are to compare the frequency of opioid refill requests, pain 
scores in the hospital, total morphine milligram equivalents used in the hospital, length 
of hospital stay, and side effect rates of nausea and sedation associated with gabapentin 
usage. 
 
 
3.0 
Outcome Measures/Endpoints 
3.1 
Primary Outcome Measures 
The primary outcome that will be measured is the percentage of patients requiring 
opioid prescription at discharge in each group based on an established algorithm for 
opioid discharge dosing from the medical literature [Margolis 2020]. If patient received 
less than 5 doses of an opioid during hospital stay, they will not receive a prescription 
for opioids on discharge. If patient received 5 or more doses, they will receive a 
prescription for opioids on discharge.  
 
3.2 
Secondary Outcome Measures 
Frequency of opioid refill requests will be measured by counting how many patients 
in each group call the office to request a new opioid prescription (if they were 
discharged without a prescription) or to request an opioid prescription refill (if they were 
discharged with a prescription) within the 6-week postoperative time period. 
 
Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 
being no pain and 10 being worst pain. Pain score collected will be pain recorded at 12 
hours after arrival to the floor and highest score during hospital stay. This scale was 
chosen because this is already the standard of nursing care for assessing patient pain. 
Nursing staff assesses pain via numeric rating scale every 4 hours on arrival to the floor. 
 
Total morphine milligram equivalents used will be calculated by converting total PO 
and IV opioids used postoperatively until hospital discharge to morphine milligram 
equivalents using the opioid equianalgesic chart. 
 
Length of stay will be measured in hours by time of registration for surgery to time of 
discharge from hospital. 
 
Nausea will be measured by the number of “as needed” antiemetics the patient 
received postoperatively. 
 
Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered 
scale that the patient will complete at 10AM on postoperative day 1. 
 
3.3 
Tertiary/Exploratory/Correlative Outcome Measures 
 


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The following demographic data will be extracted from the initial history and physical 
note, as these are standardly collected:  age (year), race (White, Black, Hispanic, Asian, 
Other), BMI, tobacco use (current, former, never), menopause status (premenopausal, 
postmenopausal), Charlson Comorbidity Index (a calculation using patient’s 
comorbidities to predict estimated 10-year survival), number of prior abdominal/pelvic 
surgeries, and stage of prolapse. 
 
The following intraoperative data will be collected from the immediate postoperative 
note written by the surgeon:  estimated blood loss and type of surgery (native tissue 
laparoscopic, native tissue vaginal, mesh-augmented laparoscopic, obliterative). 
 
Duration of surgery (from skin incision to closure) and ASA physical status class will be 
collected from the IntraOp nursing record. 
 
 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
• 
Women > 18 years old 
• 
English-speaking 
• 
Stage > 2 pelvic organ prolapse 
• 
Undergoing pelvic organ prolapse procedure (including native tissue vaginal 
procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic 
procedure, obliterative procedure) 
• 
Planning overnight stay 
 
4.2 
Exclusion Criteria 
• 
Renal dysfunction (creatinine clearance <60 mL/min) 
• 
Allergy to acetaminophen and ibuprofen 
• 
Allergy to gabapentin 
• 
Patients on a Controlled Substance Agreement or Opioid Contract from 
another provider. This information is available in the IU Health electronic medical record, 
Cerner. 
 
 
5.0 
Study Design 
 
This will be a 2-arm single-center double-blinded randomized controlled noninferiority trial of 
women undergoing prolapse repair with planned overnight hospitalization. Patients will be 
screened for eligibility at their preoperative consultation visit and consented at that time. 
Patients will be randomized to receive gabapentin 300 mg preoperatively and placebo twice 
daily postoperatively or gabapentin 300 mg preoperatively and 300 mg twice daily 
postoperatively. All patients will also receive acetaminophen 1,000 mg and ibuprofen 600 mg 
preoperatively and scheduled acetaminophen 1,000 mg every 6 hours and ibuprofen 600 mg 
every 6 hours postoperatively. They will have oxycodone 5 mg every 6 hours as needed for pain 
and ondansetron 4 mg as needed for nausea or vomiting. During morning rounds on 
postoperative day 1, patients will be given the Stanford Sleepiness Scale to complete before 
10AM. All patients will be discharged with acetaminophen 1,000 mg every 6 hours and 
ibuprofen 600 mg every 6 hours as needed for pain. Patients who received <5 doses of as-


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needed oxycodone during hospital stay will not receive a prescription for oxycodone. Patients 
who received 5 or more doses will receive a prescription for oxycodone. The medical record will 
be queried at 6 weeks postoperatively to complete case report forms and obtain demographic 
data in addition to outcome measures. 
 
 
 
Preop Visit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Surgical 
Admission 
 
 
 
 
 
 
 
 
Postop 
Visit 
 
 
 
6.0 
Enrollment/Randomization 
 
Patients will be identified for possible enrollment at their preoperative consultation. During this 
visit, surgical plan for management of pelvic organ prolapse is finalized. English-speaking 
women > 18 years old with Stage > 2 pelvic organ prolapse planning laparoscopic 
sacrocolpopexy, laparoscopic uterosacral ligament suspension, vaginal native tissue repair 
(intra- or extraperitoneal colpopexy or obliterative surgery) with or without concomitant 
hysterectomy requiring overnight hospital stay will be eligible. Patients will have Pre-Anesthesia 
Testing for assessment of renal function (creatinine clearance) on the same day as the 
N=110:  Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria.  Obtain demographic data.  Document. 
6-week postoperative visit  
Review postoperative phone calls to assess if patient requested new oxycodone 
prescription or refill.  
Randomize 
1:1 
Group 1:  preop 
gabapentin 
Group 2:  preop/postop 
gabapentin 
Preoperatively: gabapentin 300 mg, acetaminophen 1,000 mg, ibuprofen 600 mg 
Postoperatively:  gabapentin 300 
mg twice daily, acetaminophen 1,000 
mg every 6 hours, ibuprofen 600 mg 
every 6 hours 
Postoperatively:  placebo twice daily, 
acetaminophen 1,000 mg every 6 hours, 
ibuprofen 600 mg every 6 hours 
Collect intraoperative data (type of surgery, estimated blood loss), duration of surgery, ASA 
class, length of hospital stay, pain score at 12 hours, highest postoperative pain score 
recorded, whether patient needed/received antiemetic, Stanford Sleepiness Scale 
administered after morning rounds on postoperative day #1, total morphine milligram 
equivalents used postoperatively until discharge, whether patient received narcotic 
prescription at discharge 


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preoperative visit. Patients will be approached by research personnel (principal investigator or 
sub-investigators) to participate in the study. If they are not excluded from study participation, 
they will be counseled on potential risks, benefits, and alternatives to study participation. Any 
questions potential subjects have regarding the study will be answered in a language 
understandable to them at the conclusion of the visit. Study personnel will counsel potential 
subjects that they will be randomized to receive either the current standard of postoperative 
care (scheduled acetaminophen every 6 hours, scheduled ibuprofen every 6 hours, and 
scheduled gabapentin twice daily with oxycodone “PRN” or “as needed”) or the current 
standard of care without gabapentin. Patients who are willing to participate in the study will be 
asked to sign informed consent/HIPAA Authorization form establishing the privacy and 
confidentiality standards for the study. Study subjects will receive copies of both signed forms.  
 
An online random number generator (www.randomizer.org) will be used to create the random 
number set. This set will be used by the inpatient pharmacy to assign patients to one of two 
treatment groups upon their arrival for surgery:  the preoperative gabapentin/postoperative 
placebo (which will receive gabapentin preoperatively and placebo postoperatively) or the 
preoperative/postoperative gabapentin group (which will receive gabapentin preoperatively and 
postoperatively). The patient and the surgical team will be blinded to group randomization. 
 
Case report forms will be used to collect demographic data and outcome measures at the 6-
week postoperative visit. Data from case report forms will be entered into a secure and private 
REDCap database. Pharmacy will be contacted to reveal study group assignments for data 
analyses after enrollment is completed.  
 
 
7.0 
Study Procedures 
 
All patients will arrive at the preoperative unit of the hospital prior to surgery. They will receive 
the current standard of care for preoperative medications:  acetaminophen 1,000 mg, ibuprofen 
600 mg, and gabapentin 300 mg. They will then be induced with general anesthesia per the 
Anesthesiologists preference and undergo surgical prolapse repair. After surgery, they will be 
moved to the post-anesthesia care unit for close postoperative monitoring and initiation of 
postoperative pain regimens. After confirming stabilization in the PACU (usually 1-2 hours), 
patients will be moved to the medical floor for standard postoperative care. Patients in the 
preoperative/postoperative gabapentin group will receive the standard postoperative pain 
regimen:  acetaminophen 1,000 mg every 6 hours, ibuprofen 600 mg every 6 hours, and 
gabapentin 300 mg every 12 hours. Patients in the preoperative gabapentin/postoperative 
placebo group will receive acetaminophen 1,000 mg PO every 6 hours, ibuprofen 600 mg PO 
every 6 hours, and placebo every 12 hours. Both groups will have oxycodone 5 mg PO every 4 
hours available for “PRN” or “as needed” for pain control. Both groups will also have 
ondansetron available as needed for nausea. Pain is assessed by nursing staff every 4 hours 
based on established hospital-based protocols. Pain is assessed by asking the patient to rate 
their pain on a numeric rating scale from 0-10 with 0 being no pain and 10 being worst pain 
imaginable. On postoperative day 1, patients will be rounded on by a member of the study 
personnel. They will be provided the Stanford Sleepiness Scale and asked to complete this prior 
to 10AM. 
 


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Remaining data (demographics, surgical variables, length of stay, whether patient required 
opioid prescription at discharge, whether patient called within 6 weeks to request opioid 
prescription or refill) will be collected from chart review. 
 
8.0 
Study Calendar 
 
 
Preop Visit 
Surgical Admission 
6-week Postop Visit 
Demographics 
x 
 
 
Intraoperative data 
 
x 
 
Duration of surgery 
 
x 
 
Length of stay 
 
x 
 
Pain at 12 hours 
 
x 
 
Pain, highest during 
hospital admission 
 
x 
 
Nausea (whether 
patient received 
antiemetics or not) 
 
x 
 
Morphine milligram 
equivalents used 
postoperatively 
 
x 
 
Stanford Sleepiness 
Scale 
 
x 
 
Opioid prescription at 
discharge 
 
x 
 
Opioid refill/new 
prescription request 
 
 
x 
 
 
9.0 
Reportable Events 
 
The current standard of postoperative care involves scheduled acetaminophen, ibuprofen, and 
gabapentin in addition to “as needed” oxycodone. The preoperative gabapentin/postoperative 
placebo group will receive placebo rather than gabapentin postoperatively. As such, anticipated 
risks of study participation include risk of inadequate postoperative pain control, though this is 
unlikely as patients will also have access to oxycodone on an as-needed basis. As such, a 
foreseeable risk to the study will be risk of receiving more “as needed” oxycodone to achieve 
pain control for patients in this group. Oxycodone 5 mg will be available every 6 hours as 
needed. This is the lowest initial dosage and frequency of administration recommended for 
oxycodone [FDA oxycodone]. This dosage and frequency is already part of standard of care for 
our postoperative patients. This essentially negates the risk of respiratory depression from 
excessive opioid use.  
 
Should an unexpected adverse event, protocol deviation, or consent violation occur, this will be 
reported to the IRB within 5 business days of the study personnel becoming aware, as per the 
IU HRPP Reportable Events section 2.1. Collection of adverse events will begin at time of 
consent at the preoperative consultation visit. 
 
10.0 Data Safety Monitoring 


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Our current standard of care is to administer gabapentin both preoperatively and 
postoperatively. The intervention in this study is to only administer gabapentin preoperatively to 
determine if this approach is noninferior to preoperative and postoperative gabapentin with 
respect to postoperative pain control. The potential benefits of only administering gabapentin 
preoperatively is the reduction of side effect risk rates associated with elimination of 
postoperative dosing. As we will be administering less medication, this is only a slightly greater 
than minimal risk study. 
 
The study team, including the principal investigator and co-investigators, will be responsible for 
the Data Safety Monitoring Plan as this is a minimal risk study at a single site with a small 
number of subjects. The study team will be responsible for ensuring data quality, subject 
recruitment, subject accrual, and subject retention through continuous, close monitoring. 
Privacy will be protected by keeping patient consent forms, all case report forms, and Stanford 
Sleepiness Scales in a locked filing cabinet to which only the principal investigator has a key. 
Patient demographics, surgical details, and postoperative course are already kept private and 
confidential via storage in the electronic medical record which is password protected at sign on 
to the computer operating system. Data from case report forms entered into a REDCap 
database will be kept private and confidential via storage on computer files that are password 
protected at multiple levels:  1) sign on to the computer, 2) sign on to REDCap via Duo two-
factor authentication.  
 
The only anticipated risk or adverse event is inadequate postoperative pain control, which is 
unlikely as patients in both groups will have access to oxycodone as-needed. Differential opioid 
pain medication requests between the two groups will be monitored closely by hospital nursing 
staff. A physician is reachable at any time via DiagNotes, a real-time messaging system, should 
any concerns arise. Unexpected adverse events will be reported to the IRB within 5 business 
days by the principal investigator. 
 
11.0 Study Withdrawal/Discontinuation 
 
Study participants have the right to withdraw from this study at any time and for any reason, or 
no reason at all. There are no legal requirements for study participants to communicate their 
withdrawal in writing. In fact, they have the right to just stop coming to visits allowing the 
principal investigator to deduce that they have withdrawn. Withdrawal from study participation 
will not affect their postoperative care.  
 
12.0 Statistical Considerations 
 
Assuming a 15% or less dropout rate, 130 patients will need to be recruited to reach a sample 
size of 110 patients. Sample size was calculated for a noninferiority trial. Assuming 23.1% of 
patients who receive preoperative and postoperative gabapentin in addition to scheduled 
acetaminophen and ibuprofen require an opioid prescription at discharge and a 20% non-
inferiority margin, 55 patients per arm are required to achieve a power of 80% with a 
significance level of 0.05 [Margolis 2020]. 
 
Two group comparisons of normally distributed study variables will be compared using the 
Student’s T-test. Two group comparisons of nonnormally distributed study variables will be 


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compared using the Mann-Whitney U Test. K group categorical variables will be compared 
across our two treatment groups using the chi-square test for association. 
 
Our primary outcome of interest is the percentage of study subjects receiving an opioid 
prescription at discharge. Given the noninferiority study design, the null hypothesis is that the 
difference in the percentage of subjects who receive an opioid prescription in the preoperative 
gabapentin/postoperative placebo group will exceed 20% compared to the 
preoperative/postoperative gabapentin group. The alternative hypothesis is that the difference 
in the percentage of subjects who receive an opioid prescription in the preoperative 
gabapentin/postoperative placebo group will be less than 20% compared to the 
preoperative/postoperative gabapentin group. 
 
Chi-square test for association with relative risk estimates will be calculated to compare the 
percentage of study subjects receiving opioid prescriptions at discharge between our two 
treatment groups. We will accept our preoperative gabapentin/postoperative placebo group as 
noninferior to our preoperative/postoperative gabapentin group if the difference in percentage 
of subjects receiving opioid prescription at discharge is less than 20% between the two groups 
(alternative hypothesis). 
 
13.0 Statistical Data Management 
 
Data will be collected via paper case report forms which will be stored in a locked filing cabinet 
accessible only to the primary investigatory. Data will then be entered into REDCap and stored 
electronically prior to export into SPSS for data analysis. 
 
14.0 Privacy/Confidentiality Issues 
 
With exception of the Stanford Sleepiness Scale, data is stored in the electronic medical record 
as part of standard clinical care. Study personnel are also the patients’ surgeons, and as such 
have legitimate justification to having access to the study participants’ protected health 
information (PHI). All PHI collected will be de-identified using the Safe Harbor Method outlined 
in the IU HRPP Policy Statement for Use of Protected Health Information section 2.3. Study 
participants will be assigned a study number at enrollment. The study log will be secured in a 
locked filing cabinet to which only the principal investigator has a key. The de-identified 
database created from case report forms will also be stored in the locked filing cabinet. Only the 
pharmacy will have knowledge of group randomization. Group randomization assignments will 
not be accessed until all case report forms have been filled out, at which point each subject will 
be linked to their group and data will be analyzed. None of the personal health information, 
case report forms, or Stanford Sleepiness Scales will be made available for disclosure beyond 
the scope of this study. 
 
 
15.0 Follow-up and Record Retention 
 
It will require approximately 18 months to enroll 130 study participants for this study protocol, 
so we expect to be completed by September 30, 2022. All records produced or collected in 
connection with our research project, shall be retained for a period of three years from the date 


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of study closure with the IRB, consistent with Indiana University Human Research Protection 
Program section – Research Data Management section 2.2. 
 
16.0 References 
 
ROXYBOND (oxycodone hydrochloride) [package insert]. U.S. Food and Drug Administration 
website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf. 
Revised September 2018. 
 
NEURONTIN (gabapentin) [package insert]. U.S. Food and Drug Administration website. 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129
s046lbl.pdf. Revised October 2017. 
 
FDA Safety Communication:  FDA warns about serious breathing problems with seizure and 
nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica 
CR). https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-
breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin. December 2019. 
 
Stone R, Carey E, Fader AN, Fitzgerald J, Hammons L, Nensi A, Park AJ, Ricci S, Rosenfield R, 
Scheib S, Weston E. Enhanced Recovery and Surgical Optimization Protocol for Minimally 
Invasive Gynecologic Surgery: An AAGL White Paper. J Minim Invasive Gynecol. 2021 
Feb;28(2):179-203.  
 
ACOG Committee Opinion No. 750: Perioperative Pathways: Enhanced Recovery After Surgery. 
Obstet Gynecol. 2018 Sep;132(3):e120-e130. doi: 10.1097/AOG.0000000000002818. Erratum 
in: Obstet Gynecol. 2019 Jun;133(6):1288.  
 
Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, 
Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez 
PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery 
After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 
May;29(4):651-668. 
 
Margolis B, Andriani L, Baumann K, Hirsch AM, Pothuri B. Safety and Feasibility of Discharge 
Without an Opioid Prescription for Patients Undergoing Gynecologic Surgery. Obstet Gynecol. 
2020 Dec;136(6):1126-1134. 
 
 
17.0 Appendix 
 
A – Case Report Form  
B – Stanford Sleepiness Scale 
 
 
 
 
 
 


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Appendix A 
 
Perioperative Gabapentin Study – Case Report Form 
 
Subject # _____ 
 
Age:  _____ 
 
Race (circle one):     White     Black     Hispanic     Asian     Other 
 
BMI:  _____ 
 
Tobacco use (circle one):     Current     Former     Never 
 
Menopause status (circle one):     Premenopausal     Postmenopausal 
 
Number of prior abdominal/pelvic surgeries: _____ 
 
Stage of prolapse (circle one):     I     II     III     IV 
 
Charlson Comorbidity Index:  _____ 
 
Type of surgery (circle one):     Obliterative     Native-tissue vaginal      Native-tissue 
laparoscopic     Mesh-augmented laparoscopic 
 
Estimated blood loss (mL):  _____ 
 
ASA class:  _____ 
 
Duration of surgery (hours):  _____ 
 
Pain at 12 hours after arrival to floor:  _____ 
 
Pain, highest recorded:  _____ 
 
Antiemetics (number used):  _____ 
 
Stanford Sleepiness Scale:  _____ 
 
Length of hospital stay (hours):  _____ 
 
Total morphine milligram equivalents used after arrival to floor (mg):  _____ 
 
Opioid prescription at discharge (circle one):     Yes     No 
 
Opioid prescription refill/new prescription requested within 6 weeks (circle one):     Yes     No 


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Appendix B