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Clinical Trials/NCT05301595
NCT05301595
Withdrawn
N/A

Transversus Abdominus Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia After Abdominal-based Free Tissue Transfer for Breast Reconstruction After Mastectomy

Ottawa Hospital Research Institute1 site in 1 countryApril 2022
ConditionsBreast Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Ottawa Hospital Research Institute
Locations
1
Primary Endpoint
Quality of Recovery-15 survey
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2022
End Date
March 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moein Momtazi

Plastic and Reconstructive Surgeon

Ottawa Hospital Research Institute

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

Outcomes

Primary Outcomes

Quality of Recovery-15 survey

Time Frame: post-operative day #1

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.

Secondary Outcomes

  • Pain visual analog scale(1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours)
  • Quality of Recovery-15 survey(post-operative day #3)
  • Time elapsed before first analgesic requirement(post-operative day #0 to 3)
  • Surgical complication(post-operative day #0 to 3)
  • Block complication(post-operative day #0 to 3)
  • Total analgesic drug requirements(post-operative day #0 to 3)
  • Ambulation(post-operative day #0 to 3)
  • Total antiemetic drug requirements(post-operative day #0 to 3)

Study Sites (1)

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