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Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management

NCT02944656 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2019-08-08

Study results available
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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.

Conditions

Interventions

DRUG

Gabapentin

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.

DRUG

Placebo

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.

Sponsors & Collaborators

Principal Investigators

  • Lisa Haddad, MD, MS, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2018-06-26
Completion
2018-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02944656 on ClinicalTrials.gov