Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study seeks to identify whether the addition of liposomal bupivacaine to regular bupivacaine and saline administered via surgical transversus abdominis plane (TAP) block will reduce the cumulative opioid dose in the first 48 hours after cesarean. 60 women scheduled for cesarean at Unity-Point Health Meriter Hospital in Madison, Wisconsin will be enrolled and can be expect to be on study for up to 6 weeks post-partum.

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

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: UnityPoint Health-Meriter; UnityPoint Health-Meriter Foundation
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Maternal age greater than or equal to 18

• Singleton or multifetal pregnancy

• Able to receive neuraxial analgesia

• Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery at UnityPoint-Health Meriter with adequate time to consider and consent to the study

• Able to provide consent in English

Exclusion Criteria:

• Known hypersensitivity to bupivacaine or liposomal bupivacaine (defined as a history of a reaction or allergy to bupivacaine (injectable, intravenous, or transdermal) reported by patient or documented in the medical record) or patient report

• Plan by the obstetrical provider to inject bupivacaine or other local anesthetic into the cesarean incision due to potential differences in pain levels.

• Contraindication to regional analgesia

• Positive urine drug screen at admission to the hospital, if ordered for clinical purposes.

• Current opioid use or opioid use disorder per patient report or documented in the medical record or the Enhanced Prescription Drug Monitoring Program (ePDMP) (reviewed by Principal Investigator 1-14 days prior to surgery)

• Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined as opioid use on most days for greater than 3 months

• Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation)

• Planned vertical midline incision

• Presence of renal dysfunction precluding the use of non-steroidal anti-inflammatory drugs (NSAIDs)

• Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy

• Coagulopathy

• Planned discharge from the hospital less than 48 hours postpartum