Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cesarean Section Complications
- Opioid Use
- Pain
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The purpose of this study is to determine whether liposomal bupivacaine administered via surgical TAP block at the time of Cesarean delivery will reduce the total dose of opioids received. The hypothesis is that liposomal bupivacaine will reduce the total dose of opioids received in the immediate 48...
The purpose of this study is to determine whether liposomal bupivacaine administered via surgical TAP block at the time of Cesarean delivery will reduce the total dose of opioids received. The hypothesis is that liposomal bupivacaine will reduce the total dose of opioids received in the immediate 48 hours post-delivery. Secondary outcomes will include participant self-reported pain scores, participant-reported incidence of side effects, and development of objective complications such as dysrhythmias. Other outcomes collected will include length of stay, time to first rescue analgesic medication, total dose of opioids at 12, 24, 36, 72 hours and during the hospital stay, use of supplemental oxygen during hospitalization, breastfeeding rates, both exclusive and in combination with formula use, amount of opioid prescribed at discharge and whether refills were requested or administered, rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen scores. Neonatal outcomes such as fetal weight, five-minute Apgar scores and development of adverse outcomes such as neonatal intensive care unit (NICU) admission will also be collected because NICU admission can impact maternal opioid use. Primary Objective: To determine whether liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce the total dose of opioids received in the first 48 hours after surgery. Hypothesis: The hypothesis is that liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce the total dose of opioids received in the first 48 hours after surgery. Developmental Sub Aim: If liposomal bupivacaine administered via surgical TAP block does reduce the total dose of opioids received, to determine the degree of the reduction in order to allow for an adequately powered randomized-controlled trial. Secondary Objective: To determine whether liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce patient-reported pain scores and opioid-related side effects, including respiratory compromise. Hypothesis: The hypothesis is that liposomal bupivacaine administered via surgical TAP block at the time of cesarean will reduce patient-reported pain scores and opioid related side effects.
Tracking Information
- NCT #
- NCT04897841
- Collaborators
- UnityPoint Health-Meriter Foundation
- UnityPoint Health-Meriter
- Investigators
- Principal Investigator: Kathleen M Antony, MD, MSCI University of Wisconsin, Madison