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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05301595
• Other study ID #: 20210817-01H
• Status: Withdrawn
• Phase: N/A
• Start date: April 2022
• Est. completion date: March 2023

Study information

• Verified date: November 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• TAP block
Please see description of TAP block group.
• QL Block
Please see description of QL block group.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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) 2. 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 #2
Secondary	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) 3. 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 #3
Secondary	Pain visual analog scale	Pain visual analog scale (VAS) is a 1 to 10 continuous scale used to determine the intensity of a patient's pain at any given time. For any given time, the minimum value is 1 (no pain) and the maximum value is 10 (pain as bad as it could possibly be). The lower the number, the less intense the pain and better outcome.	1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours
Secondary	Time elapsed before first analgesic requirement	Time that has elapsed since surgery before first analgesic medication is needed.	post-operative day #0 to 3
Secondary	Total analgesic drug requirements	The total amount of analgesic medication patient requires in the first 3 days after surgery	post-operative day #0 to 3
Secondary	Total antiemetic drug requirements	The total amount of antiemetic medication patient requires in the first 3 days after surgery	post-operative day #0 to 3
Secondary	Ambulation	Ability of patient to ambulate (e.g. up to chair, mobilizing with assistance, mobilizing independently) in the first 3 days after surgery.	post-operative day #0 to 3
Secondary	Surgical complication	Any acute surgical complications experienced by the patient in the first three days after surgery.	post-operative day #0 to 3
Secondary	Block complication	Any acute nerve-block related complications experienced by the patient in the first three days after surgery.	post-operative day #0 to 3