Clinical trial NCT06962150: TAP vs QL Block for DIEP Flap Breast Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Deep Inferior Epigastric Perforator Flap Breast Reconstruction
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48
timeFrame: Postoperative hour 0 to 48
measure: Opioid consumption during the first 48 postoperative hours
timeFrame: Postoperative hour 0 to 48
Secondary outcomes:
measure: Operation duration
timeFrame: Intraoperative period
measure: Time spent in the post-anesthesia care unit
timeFrame: Postoperative - interval immediately following surgery
measure: Length of hospital stay
timeFrame: Postoperative - approximately 48 hours
measure: Time to ambulation
timeFrame: Postoperative hour 0 to 48
measure: Costs associated with each intervention
timeFrame: Participant check-in to discharge, approximately 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Haripriya Ayyala, MD
role: PRINCIPAL_INVESTIGATOR
References: