Clinical trial NCT03335436: Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cesarean Delivery
Pain Management
Keywords: buprenorphine maintenance
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total opioid use 24 hours after cesarean delivery
timeFrame: 24 hours after cesarean delivery
measure: Total opioid use at time of hospital discharge after cesarean delivery
timeFrame: From the end of cesarean delivery to the time of hospital discharge after cesarean delivery, approximately 4 days
Secondary outcomes:
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 4 hours post-partum
timeFrame: 4 hours post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 4 hours post-partum
timeFrame: 4 hours post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 24 hours post-partum
timeFrame: 24 hours post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 24 hours post-partum
timeFrame: 24 hours post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 48 hours post-partum
timeFrame: 48 hours post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 48 hours post-partum
timeFrame: 48 hours post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 30 days post-partum
timeFrame: 30 days post-partum
measure: Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 30 days post-partum
timeFrame: 30 days post-partum
measure: Presence of persistent pain
timeFrame: 30 days post-partum
measure: Return to normal daily function
timeFrame: 30 days post-partum
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Holly B Ende, M.D,
role: PRINCIPAL_INVESTIGATOR
References: