Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
Purpose
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).
Conditions
- Cesarean Delivery
- Pain Management
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
More Details
- Status
- Withdrawn
- Sponsor
- Vanderbilt University Medical Center
Study Contact
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.