Gabapentin for Perioperative Pain Relief in Surgical Abortion

Study Overview
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Brief Summary
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Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

Detailed Description
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A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.

Official Title
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Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial

Conditions
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Pain Control

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age. English or Spanish speaking eligible for office-based surgical pregnancy termination Exclusion Criteria: present use of gabapentin or pregabalin, renal disease sensitivity or allergy to gabapentin Missed abortion

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
Interventional Model Description: double-blind placebo-controlled randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin Arm<br>Gabapentin 600 mg given 1-2 hours prior to surgical abortion | Drug: Gabapentin<br>* Preoperative treatment with Gabapentin<br>|
| Placebo Comparator: Placebo Arm<br>Placebo (vit C) given 1-2 hours prior to surgical abortion | Drug: Placebos<br>* Preoperative treatment with Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain | 5 minutes postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score 24 | Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain | 24 hours postop | 
| Nausea | Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme | 24 hours postoperative | 
| Vomiting | Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme | 24 hours postoperative | 
| Pain Score at 30 Minutes Postoperative | 100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain | 30 minutes postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin Abortion