Stopping Opioid Overuse in Obstetrics To Halt Exposure Trial

• Status: Enrolling by invitation
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Missouri, Kansas City
• Collaborator: Truman Medical Center
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Unlabored, scheduled primary or repeat cesarean delivery

• Cesarean performed by obstetrician or surgically-trained family medicine physician

• Ability to complete numeric pain scale assessment and surveys

• Patients who do not speak English but are able to converse via an interpreter both in person and by phone

Exclusion Criteria:

• Complications requiring return to the operating room

• Unscheduled deliveries

• <18 years old, >45 years old

• Twin deliveries

• Preterm deliveries (<37 wks)

• Current or previous history of opioid-substance use disorder according to patient report or medical chart

• Prescription of opioid medication filled in previous 30 days prior to delivery according to patient report, documentation in electronic medical record, or documentation in the prescription drug monitoring program

• Allergy to local anesthetics or NSAIDs

• Cardiovascular disease, eg arrhythmia, or ASA (American Society of Anesthesiologists) Class III or higher

• Diagnosis of liver disorder or dysfunction including fatty liver of pregnancy, preeclampsia with severe features including liver or kidney involvement

• Known significant renal disease, oliguria, or Cr >1.1.

• Platelet count less than or equal to 90k or rapid decline in third trimester or other coagulopathy

• Infection overlying the regional anesthesia site

• Hypovolemia prohibiting regional anesthesia

• General anesthesia