Stopping Opioid Overuse in Obstetrics To Halt Exposure Trial

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial Description

Nearly 1 in 3 women in the US deliver by cesarean delivery. After cesarean delivery, approximately 75-87% percent of women are discharged from the hospital with an opioid prescription. Most women fill that prescription and 1% continue to use those opioids 90 days after delivery despite no longer requiring them for pain control, predisposing them to opioid dependence. This study aims to determine if transverse abdominis plane (TAP) block using bupivacaine liposome suspension injection (EXPAREL®) significantly reduces the use of opioid medications after discharge in women undergoing scheduled cesarean delivery. The study is a proposed double-blinded, randomized controlled trial. Pregnant women who have completed 37 weeks gestation and are scheduled for cesarean delivery will be randomized to receive a TAP block with 80 ml of mixed liposomal bupivacaine or saline. Based on its use in other surgical settings, the investigators hypothesize that women who receive a liposomal bupivacaine TAP block will use significantly less opioids by postoperative day 7 as calculated in morphine milligram equivalents. In addition to overall consumption of opioids after discharge, other aims to be studied include inpatient opioid use, effect on pain scores, rates of postpartum depression, patient-perceived quality of breastfeeding, patient quality of recovery, and composite adverse outcomes. With better overall pain control and less dependence on opioids postpartum, liposomal bupivacaine TAP blocks at the time of scheduled cesarean delivery may offer a highly effective analgesic alternative that can help shift the tide in the ongoing opioid epidemic among reproductive females. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04680221
Study type	Interventional
Source	University of Missouri, Kansas City
Contact
Status	Enrolling by invitation
Phase	Phase 4
Start date	March 1, 2021
Completion date	June 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stopping Opioid Overuse in Obstetrics To Halt Exposure Trial — SOOOTHE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms