Gabapentin for Perioperative Pain Relief in Surgical Abortion

NCT04292171 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 734275-7
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Control

Keywords

Gabapentin Abortion

Outcome Measures

Primary Outcomes (1)

• Pain Score

  100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain

  5 minutes postoperative

Secondary Outcomes (4)

• Pain Score 24

  24 hours postop

• Nausea

  24 hours postoperative

• Vomiting

  24 hours postoperative

• Pain Score at 30 Minutes Postoperative

  30 minutes postoperative

Study Arms (2)

Gabapentin Arm

ACTIVE COMPARATOR

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

Drug: Gabapentin

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Gabapentin DRUG

Preoperative treatment with Gabapentin

Gabapentin Arm

Placebos DRUG

Preoperative treatment with Placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• present use of gabapentin or pregabalin,
• renal disease
• sensitivity or allergy to gabapentin
• Missed abortion

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

Birth Control Care Center

Las Vegas, Nevada, 89104, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Adam V. Levy MD
• Organization: University of Nevada Las Vegas School of Medicine

adam.levy@unlv.edu

702-671-2300

Study Officials

• Vani Dandolu, MD

  University of Nevada School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: pharmacy prepared sequentially numbered opaque bottles with identical capsules containing either placebo (vit c) or Gabapentin 600mg, block randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, OB/GYN

Model Details: double-blind placebo-controlled randomized controlled trial

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: March 2, 2020
• Study Start: May 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: December 2, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication and terminating 5 years following
• 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.

Locations

US (1)