Liposomal Bupivacaine for Postoperative Pain
(SOOOTHE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Missouri, Kansas City

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women aged 18-45 having a scheduled cesarean delivery, who can communicate in English or with an interpreter. They must be able to do pain assessments and haven't used opioids recently. It's not for those with unscheduled deliveries, opioid use disorder, certain health issues like severe kidney disease, allergies to local anesthetics/NSAIDs, or complications requiring additional surgery.

Inclusion Criteria

Ability to complete numeric pain scale assessment and surveys

I need an interpreter to communicate in English.

I am scheduled for a cesarean delivery without complications.

+1 more

Exclusion Criteria

Deliveries that were not scheduled in advance.

I have kidney problems or my creatinine level is above 1.1.

You were born before 37 weeks of pregnancy.

+12 more

Participant Groups

The study tests if a TAP block using liposomal bupivacaine reduces the need for opioid painkillers after C-sections through day 7 post-op. It's a double-blind trial where patients are randomly assigned to receive either the drug or saline as control without knowing which one they get.

2Treatment groups

Active Control

Placebo Group

Group I: TreatmentActive Control2 Interventions

The transversus abdominis plane block is a procedure involving injection of a local anesthetic solution into the abdominal plane between the internal oblique muscle and the transversus abdominis muscle. In our institution, this is done under ultrasound guidance which is the current standard to improve efficacy and limit complications. Liposomal bupivacaine uses an innovative technology consisting of lipid-based particles containing active pharmaceutical agent (bupivacaine) which extends the duration of the medication through a process of gradual release for metabolism.This drug delivery technology extends the duration of action to up to 96 hours when given at a dose of 266 mg liposomal bupivacaine admixed with 30 ml of bupivacaine 0.25% and 30 ml of saline. Forty ml of solution is deposited on the left side of the abdomen and 40 ml on the right.

Group II: ControlPlacebo Group2 Interventions

The transversus abdominis plane block will be performed under ultrasound guidance with deposition of 80 ml of saline (40 ml on either side).