Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (CD).

Study Overview

• Status: Withdrawn
• Conditions: Pain Management; Cesarean Delivery
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebo

Detailed Description

Many strategies have been suggested to improve post-CD pain management in parturients on buprenorphine. While effective pain relief can be achieved, women maintained on buprenorphine during pregnancy have been shown to require up to 50% more opioids after CD compared to women with opioid use disorder not on a maintenance regimen. The perioperative use of gabapentin has been shown to reduce pain scores and opioid consumption following a variety of surgeries, ranging from cardiac bypass to total abdominal hysterectomy. The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective CD.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• singleton, term pregnancy
• currently on buprenorphine maintenance therapy
• scheduled for elective CD under spinal anesthesia

Exclusion Criteria:

• use illicit drugs or relapse during the last trimester of pregnancy
• positive drug screen at the time of delivery
• allergies to any medications used in the study
• taking prescribed gabapentin at the time of admission for CD
• contraindications to neuraxial anesthesia or require general anesthesia for CD
• designated ASA physical status 4 or above

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
Experimental: Gabapentin; Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery	Drug: Gabapentin; Participants will receive Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery
Placebo Comparator: Placebo; Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery	Drug: Placebo; Participants will receive Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid use 24 hours after cesarean delivery	Total opioid use tallied in morphine milligram equivalents at 24 hours after cesarean delivery	24 hours after cesarean delivery
Total opioid use at time of hospital discharge after cesarean delivery	Total opioid use tallied in morphine milligram equivalents from the end cesarean delivery to the time of hospital discharge after cesarean delivery	From the end of cesarean delivery to the time of hospital discharge after cesarean delivery, approximately 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 4 hours post-partum	Pain assessment using VAS at rest 4 hours post-partum when 0 is no pain and 10 is worst pain	4 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 4 hours post-partum	Pain assessment using VAS at movement 4 hours post-partum when 0 is no pain and 10 is worst pain	4 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 24 hours post-partum	Pain assessment using VAS at rest 24 hours post-partum when 0 is no pain and 10 is worst pain	24 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 24 hours post-partum	Pain assessment using VAS at movement 24 hours post-partum when 0 is no pain and 10 is worst pain	24 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 48 hours post-partum	Pain assessment using VAS at rest 48 hours post-partum when 0 is no pain and 10 is worst pain	48 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 48 hours post-partum	Pain assessment using VAS at movement 48 hours post-partum when 0 is no pain and 10 is worst pain	48 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 30 days post-partum	Pain assessment using VAS at rest 30 days post-partum when 0 is no pain and 10 is worst pain	30 days post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 30 days post-partum	Pain assessment using VAS at movement 30 days post-partum when 0 is no pain and 10 is worst pain	30 days post-partum
Presence of persistent pain	Presence of persistent pain defined as pain score greater than baseline at 30 days post-partum	30 days post-partum
Return to normal daily function	Return to normal daily function assessed with the Veterans RAND 12-item questionnaire	30 days post-partum

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Holly B Ende, M.D,, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: buprenorphine maintenance
• 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: 171688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No