Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient

Vanderbilt University Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Pain Management; Cesarean Delivery

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03335436

171688

Details and patient eligibility

About

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 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Gabapentin

Experimental group

Description:

Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery

Treatment:

Drug: Gabapentin

Placebo

Placebo Comparator group

Description:

Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery

Treatment:

Drug: Placebo