Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03335436

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cesarean Delivery Pain Management	Drug: Gabapentin Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 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 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
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 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 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
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
Presence of persistent pain [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 [30 days post-partum]
Return to normal daily function assessed with the Veterans RAND 12-item questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Holly Ende, Asst Professor, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03335436

Other Study ID Numbers:

171688

First Posted:

Nov 7, 2017

Last Update Posted:

Feb 18, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Holly Ende, Asst Professor, Vanderbilt University Medical Center

buprenorphine maintenance

Additional relevant MeSH terms:

Gabapentin

Study Results

No Results Posted as of Feb 18, 2019