TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction

NCT05301595 | Withdrawn DMC

• 1 other identifier: 20210817-01H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 survey

  Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 1. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome.

  post-operative day #1

Secondary Outcomes (9)

• Quality of Recovery-15 survey

  post-operative day #2

• Quality of Recovery-15 survey

  post-operative day #3

• Pain visual analog scale

  1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours

• Time elapsed before first analgesic requirement

  post-operative day #0 to 3

• Total analgesic drug requirements

  post-operative day #0 to 3

Study Arms (2)

TAP block

ACTIVE COMPARATOR

All patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia. Patients in this group will have bilateral sham blocks performed after PV block is complete. 2ml of normal saline will be injected under the skin bilaterally near the insertion site of a typical QL block. TAP block will be performed intraoperatively by the surgeon. The anesthesiologist will provide the surgeon with 40ml of LA mixture (ropivacaine 0.25%, epinephrine 100mcg and dexamethasone 4mg) for patients in this group. The surgeon will be blinded to the injectate content. The TAP block is performed once the abdominal flap has been harvested. The triangle of Petit is landmarked by the iliac crest inferiorly, the latissimus dorsi muscle posteriorly and the external oblique muscle anteriorly. A blunt tip needle is advanced through the external oblique fascia and internal oblique fascia. A total volume 20mL of the LA mixture will be injected per side.

Procedure: TAP block

QL block

ACTIVE COMPARATOR

All patients will have paravertebral (PV) blocks of the chest performed prior to induction of general anesthesia. Patients in this group will have QL block performed after PV block is complete. This will be performed with patients in the prone position using the transverse in-plane technique. With realtime U/S guidance, the quadratus lumborum muscle is identified before a short-bevel needle is advanced into the plane between the quadratus lumborum and psoas major muscles. Needle tip position is confirmed by separation of quadratus lumborum and psoas major upon injection. 20ml of ropivacaine 0.25%, epinephrine 50mcg and dexamethasone 2mg will be injected per side. TAP block is performed intraoperatively similar to above but with 40mL of normal saline to perform a sham block. The anesthesiologist will provide the surgeon with 40ml of normal saline in this group. The surgeon will be blinded to the injectate content.

Procedure: QL Block

Interventions

TAP block PROCEDURE

Please see description of TAP block group.

TAP block

QL Block PROCEDURE

Please see description of QL block group.

QL block

Eligibility Criteria

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

You may qualify if:

• Women (age 18 years or older) who are booked for abdominally based free flap for breast reconstruction
• Patients with America Society of Anesthesiologists (ASA) physical status class I, II and III

You may not qualify if:

• Patients not consenting for regional block
• Patients allergic to local anesthetics and adjuvants
• Patients with America Society of Anesthesiologists (ASA) physical status class IV and V
• Patients with any baseline opiate consumption
• Presence of infection at needle insertion site
• Patients with coagulopathy (INR\>1.3)
• Patients with thrombocytopenia (Platelets\<100)
• Patients on therapeutic anticoagulation

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1S1B1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Moein Momtazi, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be randomized by using forty-six sealed, opaque envelopes to receive a TAP block or QL block. This is a double-blind study. Patient, surgeon and study staff will know which group patient has been assigned to. The anesthetist will know which group you are in for logistical purposes. The patient and surgeon will not know which nerve block the patient received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic and Reconstructive Surgeon

Model Details: Patients will be randomized to receive intraoperative TAP block (Group A) or preoperative ultrasound- guided QL block (Group B).

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 29, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)