TAP vs QL Block for DIEP Flap Breast Reconstruction

NCT ID: NCT06962150

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TAP 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.

Group Type: ACTIVE_COMPARATOR

Surgeon-placed transversus abdominis plane block

Intervention Type: PROCEDURE

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.

QL 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.

Group Type: EXPERIMENTAL

Ultrasound-guided quadratus lumborum block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female ≥ 18 years of age at date of surgery
• Patient is booked for a DIEP flap breast reconstruction. Immediate and delayed reconstruction are both acceptable. Unilateral and bilateral reconstruction are both acceptable.
• English speaking or other with aid of in-person translator

Exclusion Criteria

• Patient unwilling to participate in trial
• Patient has allergy to nerve block components
• Patient is currently taking opioids for any reason

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haripriya Ayyala, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

2000035712

Identifier Type: -

Identifier Source: org_study_id