TAP vs QL Block for DIEP Flap Breast Reconstruction

NCT06962150 | Withdrawn

• 1 other identifier: 2000035712
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deep Inferior Epigastric Perforator Flap Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48

  Participants will be asked to self-report their pain using the Visual Analogue Scale (VAS) at postoperative hours 0, 2, 4, 6, 12, 24, 36, and 48. The minimum sore on the VAS is 0 (no pain) and the maximum score is 10 (worst pain).

  Postoperative hour 0 to 48

• Opioid consumption during the first 48 postoperative hours

  Participants' opioid consumption (in morphine milligram equivalents) during the first 48 postoperative hours will be recorded. (or until pt is discharged?)

  Postoperative hour 0 to 48

Secondary Outcomes (5)

• Operation duration

  Intraoperative period

• Time spent in the post-anesthesia care unit

  Postoperative - interval immediately following surgery

• Length of hospital stay

  Postoperative - approximately 48 hours

• Time to ambulation

  Postoperative hour 0 to 48

• Costs associated with each intervention

  Participant check-in to discharge, approximately 1 week

Study Arms (2)

TAP block

ACTIVE COMPARATOR

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: Surgeon-placed transversus abdominis plane block

QL block

EXPERIMENTAL

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.

Procedure: Ultrasound-guided quadratus lumborum block

Interventions

Surgeon-placed transversus abdominis plane block 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.

TAP block

Ultrasound-guided quadratus lumborum block 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.

QL block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Officials

• Haripriya Ayyala, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: By nature of the nerve block techniques, the patient, operating surgeon, and anesthesiologist will be aware of the assignments of individual participants. The statistician who will analyze the data will be blinded to the assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: May 8, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share