Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

Overview

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).

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2020

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Experimental: Gabapentin
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Holly Ende, Asst Professor – Vanderbilt University Medical Center
  • Overall Official(s)
    • Holly B Ende, M.D,, Principal Investigator, Vanderbilt University Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.