Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 following the procedure Exclusion Criteria: Allergy, sensitivity or contraindication to gabapentin Severe renal disease Currently using gabapentin or pregabalin Contraindication to outpatient abortion under local anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin group<br>This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively. | Drug: Gabapentin<br>* 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.<br>* Other names: Neurontin;|
| Placebo Comparator: Placebo group<br>This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Time of Uterine Evacuation | The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. No pain is scored as 0 and worst pain imaginable is scored as 100. | During the procedure on Study Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Pain Level | Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. No pain is scored as 0 and worst pain imaginable is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge). | Pre-procedure through post-procedure on Study Day 1 | 
| Number of Participants Using Pain Medication | The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication. | Postoperative Day 1 | 
| Perioperative Nausea | Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while worst nausea I have ever felt is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. | Pre-procedure through post-procedure on Study Day 1 | 
| Perioperative Vomiting | Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. | Pre-procedure through post-procedure on Study Day 1 | 
| Anxiety Levels | Participants reported how much anxiety they were currently experiencing on a 100-point scale where No Anxiety is scored as 0 and Extremely Anxious is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure. | Pre-procedure through post-procedure on Study Day 1 | 
| Side Effects | Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes. | 10 and 30 minutes post procedure on Study Day 1 | 
| Moderate Pain at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Moderate pain was defined according to the perception of each participant. | Postoperative Day 1 | 
| Severe Pain at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Severe pain was defined according to the perception of each participant. | Postoperative Day 1 | 
| Nausea or Vomiting at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome. | Postoperative Day 1 | 
| Vomiting Since Leaving Clinic | During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic. | Postoperative Day 1 | 
| Overall Satisfaction With the Procedure | Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied. | Postoperative Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative pain, Outpatient surgery, Obstetrics/gynecology, Pain management