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
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