Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section

• Status: Terminated
• Trial end date: 2021-05-20
• Target enrollment: 0
• Participant gender: Female

Summary

The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethasone in the TAP block to observe its effects at specific small doses. It is the hope of the investigator that the studied technique would become utilized routinely for the obstetric population following cesarean section.

The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks will prolong the duration of the block in a dose-dependent fashion. The investigators hope to improve post-operative pain following cesarean section, increase duration of TAP block with use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease opioid requirements after cesarean section.

The primary endpoint will be estimation of duration of TAP block, being assessed within 48 hours after surgery. Secondary endpoints will include pain scores both in PACU and on the floor, average pain scores, time until first opioid administration, total opioid consumption in first 48 hours, use of PONV medications, and overall patient satisfaction.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone acetate; Morphine; Ropivacaine

Criteria

Inclusion Criteria:

1. Women undergoing cesarean section delivery.

2. Patients classified as American Society of Anesthesiology (ASA) class II or III.

1. ASA II: mild systemic disease, pregnancy

2. ASA III: severe systemic disease

3. Women ≥ 18 years old

4. Neuraxial anesthesia (spinal) to be used as anesthetic technique intraoperatively for cesarean section (this is the UAB Anesthesiology standard of care).

Exclusion Criteria:

1. Any patient not classified as an ASA I or II.

2. General Anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques for cesarean section.

3. Allergy/intolerance to local anesthetic or steroids.

4. Pre-existing neurological and/or anatomical deficit that would preclude regional block.

5. Coexisting coagulopathy such as hemophilia or von Willebrand Disease

6. BMI > 40.

7. Emergency Cesarean Sections