Clinical trial NCT05301595: TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction
Official title: Transversus Abdominus Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia After Abdominal-based Free Tissue Transfer for Breast Reconstruction After Mastectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive intraoperative TAP block (Group A) or preoperative ultrasound- guided QL block (Group B).
Primary purpose: TREATMENT

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.

Detailed description: Breast reconstruction after mastectomy has seen continued growth and popularity in recent years secondary to improved surgical techniques and improved patient awareness and understanding. While implant-based reconstruction remain the most popular option, autologous tissue transfer, reconstruction of the breast with a patient's own tissues, has emerged as the gold standard for breast reconstruction, most commonly performed with abdominally-based flaps, such as the deep inferior epigastric perforator (DIEP) flap.

Postoperative pain can be a difficult challenge in patients who have undergone DIEP flap. Patients with worse postoperative pain control report worse overall satisfaction with their surgical experience.

A multimodal analgesia protocol is a key component in the postoperative care after DIEP flap. Regional nerve blocks present an adjunct to these protocols that can potentially improve the quality of recovery of these patients.

Transversus abdominus plane (TAP) blocks have been shown to be a safe and effective technique to manage postoperative pain at the abdomen in this population; lowering usage of opiates, shortening length of stay and reducing episodes of nausea and vomiting. TAP's efficacy is well-established and documented for postoperative analgesia in abdominal surgery. This can be done preoperatively by an anesthetist via ultrasound-guidance or, using traditional technique of direct visualization, intraoperatively by the operating surgeon. Surgeon-performed intra-operative TAP block are often preferred as it is less time-consuming. TAP block has become the standard abdominal regional nerve block to perform during this procedure.

More recently, QL block has emerged as an alternative to TAP block for lower abdominal surgery. The QL block is an ultrasound-guided fascial plane block performed by an anesthetist for anterior abdominal wall analgesia.

This study will compare QL block to TAP block in patients undergoing DIEP free flap breast reconstruction.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of Recovery-15 survey
timeFrame: post-operative day #1
Secondary outcomes:
measure: Quality of Recovery-15 survey
timeFrame: post-operative day #2
measure: Quality of Recovery-15 survey
timeFrame: post-operative day #3
measure: Pain visual analog scale
timeFrame: 1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours
measure: Time elapsed before first analgesic requirement
timeFrame: post-operative day #0 to 3
measure: Total analgesic drug requirements
timeFrame: post-operative day #0 to 3
measure: Total antiemetic drug requirements
timeFrame: post-operative day #0 to 3
measure: Ambulation
timeFrame: post-operative day #0 to 3
measure: Surgical complication
timeFrame: post-operative day #0 to 3
measure: Block complication
timeFrame: post-operative day #0 to 3
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Moein Momtazi, MD
role: PRINCIPAL_INVESTIGATOR
References: