Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03335436
• Other study ID #: 171688
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery
• Pain Management

Intervention

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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Presence of persistent pain	Presence of persistent pain defined as pain score greater than baseline at 30 days post-partum	30 days post-partum
Secondary	Return to normal daily function	Return to normal daily function assessed with the Veterans RAND 12-item questionnaire	30 days post-partum