Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration

Study Overview
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Brief Summary
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This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.

Official Title
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Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial

Conditions
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Other Abortion, Spontaneous Abortion

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 No contraindication to outpatient abortion No contraindication to gabapentin Fluency in English and able to provide informed consent Exclusion Criteria: Allergy, sensitivity or contraindication to gabapentin Severe renal disease Currently using gabapentin or pregalabin

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Placebo<br>Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. | Drug: Placebo<br>* Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure<br>* Other names: sugar pill;|
| Active Comparator: Group 2: Gabapentin<br>Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. | Drug: Gabapentin<br>* 600mg Gabapentin administered orally 1-2 hours prior to procedure<br>* Other names: Neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure | Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score on the 100-mm VAS | Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute | 
| Perioperative Nausea as Measured by 100-mm VAS | Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life. | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes | 
| Number of Subjects Experiencing Perioperative Vomiting |  | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes | 
| Perioperative Anxiety as Measured by the 100-mm VAS | Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious. | 5 minutes, 10 minutes, 30 minutes, discharge | 
| Number of Subjects Using Pain Medications | Pain medications included ibuprofen and oxycodone. | 24 hours post-operatively | 
| Number of Subjects Experiencing Side Effects | Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia. | 10 minutes post-procedure | 
| Pain (on a 5-point Scale) |  | Post-operative day 1 | 
| Nausea (on a 5-point Scale) |  | Post-operative day 1 | 
| Vomiting (on a 5-point Scale) |  | Post-operative day 1 | 
| Side Effects (on a 5-point Scale) |  | Post-operative day 1 | 
| General Satisfaction With the Procedure (on a 5-point Scale) |  | Post-operative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterine aspiration