Gabapentin for Perioperative Pain Relief in Surgical Abortion

Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial

Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

Study Overview

• Status: Completed
• Conditions: Pain Control
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebos

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Birth Control Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin Arm; Gabapentin 600 mg given 1-2 hours prior to surgical abortion	Drug: Gabapentin; Preoperative treatment with Gabapentin
Placebo Comparator: Placebo Arm; Placebo (vit C) given 1-2 hours prior to surgical abortion	Drug: Placebos; Preoperative treatment with Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain	5 minutes postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score 24	Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain	24 hours postop
Nausea	Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme	24 hours postoperative
Vomiting	Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme	24 hours postoperative
Pain Score at 30 Minutes Postoperative	100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain	30 minutes postoperative

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Investigators: Study Chair: Vani Dandolu, MD, University of Nevada School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Gabapentin Abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 734275-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the participant data de-identified that was collected during the study.
• IPD Sharing Time Frame: Following publication and terminating 5 years following
• IPD Sharing Access Criteria: Investigators must submit a Material Transfer Agreement for data transfer between UNLV School of Medicine and investigators institution. Investigators who demonstrate a legitimate proposal on the purpose for the data set, their intended analysis and schedule for anticipated publication will be considered. Investigators should submit their publications within 18 months of receiving the data set.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes