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

Phase 2

Completed

• Conditions: Other Abortion; Spontaneous Abortion
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT02725710
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-04-01
• Study Start: 2016-08
• Primary Completion: 2018-06-13
• Study Completion: 2018-06-14
• Status Verified: 2019-06
• Results First Submitted: 2019-06-12
• Results First Submitted QC: 2019-06-12
• Last Update Submitted: 2019-06-12
• Results First Posted: 2019-07-02
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Placebo	Placebo	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Group 2: Gabapentin	Gabapentin	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States