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Gabapentin for Perioperative Pain Relief in Surgical Abortion

NCT ID: NCT04292171

Last Updated: 2020-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-03-30

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.

Conditions

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Pain Control

Keywords

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Gabapentin Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind placebo-controlled randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
pharmacy prepared sequentially numbered opaque bottles with identical capsules containing either placebo (vit c) or Gabapentin 600mg, block randomized

Study Groups

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Gabapentin Arm

Gabapentin 600 mg given 1-2 hours prior to surgical abortion

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Preoperative treatment with Gabapentin

Placebo Arm

Placebo (vit C) given 1-2 hours prior to surgical abortion

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Preoperative treatment with Placebo

Interventions

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Gabapentin

Preoperative treatment with Gabapentin

Intervention Type DRUG

Placebos

Preoperative treatment with Placebo

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

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Adam Levy

Associate Professor, OB/GYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vani Dandolu, MD

Role: STUDY_CHAIR

University of Nevada School of Medicine

Locations

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Birth Control Care Center

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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734275-7

Identifier Type: -

Identifier Source: org_study_id