CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
Gabapentin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02944656
NCT02944656Phase 4Completed
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Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial

Emory University·interventional·Posted Oct 26, 2016·Updated Aug 8, 2019

In Brief

A Phase 4 clinical trial evaluating Gabapentin and Placebo for Pain. Completed, enrolled 114 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsSociety of Family Planning

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 26, 2016
Enrollment StartDec 8, 2016
Primary CompletionJun 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.7 years ago

Interventions

Gabapentindrug

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.

Placebodrug

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.