Transversus Abdominus Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia After Abdominal-based Free Tissue Transfer for Breast Reconstruction After Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Quality of Recovery-15 survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of Recovery-15 survey
时间窗: 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.
次要结局
- 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)
研究者
Moein Momtazi
Plastic and Reconstructive Surgeon
Ottawa Hospital Research Institute