Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

Phase 4

Withdrawn

• Conditions: Cesarean Delivery; Pain Management
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT03335436
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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).

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 Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-07
• Study Start: 2018-04-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery
Gabapentin	Gabapentin	Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery

Primary Outcome Measures

Name	Time	Method
Total opioid use 24 hours after cesarean delivery	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	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 Outcome Measures

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