Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

Study Overview
=================
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.

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

Conditions
-----------------
Cesarean Delivery, Pain Management

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery | Drug: Gabapentin<br>* 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<br>|
| Placebo Comparator: Placebo<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Presence of persistent pain | Presence of persistent pain defined as pain score greater than baseline at 30 days post-partum | 30 days post-partum | 
| Return to normal daily function | Return to normal daily function assessed with the Veterans RAND 12-item questionnaire | 30 days post-partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
buprenorphine maintenance