NCT06962150

TAP vs QL Block for DIEP Flap Breast Reconstruction

Parallel Randomized Controlled Trial Study of Surgeon-Placed Transversus Abdominis Plane vs Ultrasound-Guided Quadratus Lumborum Blocks for Postoperative Analgesia Following Autologous Abdominal-Based Flap Breast Reconstruction

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this two-arm clinical study is to compare two nerve block techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum (QL) block, in terms of how well they manage pain in the immediate postoperative period in patients undergoing deep inferior epigastric perforator flap breast reconstruction.

Detailed description

This study is a randomized trial with two parallel intervention arms comparing TAP and QL blocks for post-operative analgesia in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Participants scheduled to undergo DIEP flap breast reconstruction will be prospectively recruited and randomly allocated to receive either a surgeon-placed TAP block intraoperatively or an anesthesiologist-placed, ultrasound-guided QL block preoperatively. The overall objective of this study is to provide evidence of a best-practice procedure for managing pain post-operatively. Aim 1: To compare postoperative pain scores and total opioid consumption (in morphine milligram equivalents) in the first 48 hours postoperatively between the two study groups. Hypothesis 1: Receipt of the QL block is associated with relatively lower postoperative pain scores and reduced total opioid consumption. Aim 2: To describe any changes in operation duration, time spent in the PACU, length of stay, time to ambulation, and costs that may be associated with using the more efficacious nerve block (as determined by results related to the primary objective). Hypothesis 2: The QL block will be associated with shorter time to ambulation, time spent in the PACU, and length of stay. Because of requirements for the QL block to be administered preoperatively solely under ultrasound guidance by an anesthesiologist, receipt of the QL block is associated with increased operation time and total procedural costs compared to receipt of the TAP block.

Conditions

• Deep Inferior Epigastric Perforator Flap Breast Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Surgeon-placed transversus abdominis plane block	Participants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine.
PROCEDURE	Ultrasound-guided quadratus lumborum block	Participants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-05-08
• Last updated: 2025-05-08