Parallel Randomized Controlled Trial Study of Surgeon-Placed Transversus Abdominis Plane vs Ultrasound-Guided Quadratus Lumborum Blocks for Postoperative Analgesia Following Autologous Abdominal-Based Flap Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48
研究概览
简要总结
The purpose of this two-arm clinical study is to compare two nerve block techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum (QL) block, in terms of how well they manage pain in the immediate postoperative period in patients undergoing deep inferior epigastric perforator flap breast reconstruction.
详细描述
This study is a randomized trial with two parallel intervention arms comparing TAP and QL blocks for post-operative analgesia in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Participants scheduled to undergo DIEP flap breast reconstruction will be prospectively recruited and randomly allocated to receive either a surgeon-placed TAP block intraoperatively or an anesthesiologist-placed, ultrasound-guided QL block preoperatively. The overall objective of this study is to provide evidence of a best-practice procedure for managing pain post-operatively.
Aim 1: To compare postoperative pain scores and total opioid consumption (in morphine milligram equivalents) in the first 48 hours postoperatively between the two study groups.
Hypothesis 1: Receipt of the QL block is associated with relatively lower postoperative pain scores and reduced total opioid consumption.
Aim 2: To describe any changes in operation duration, time spent in the PACU, length of stay, time to ambulation, and costs that may be associated with using the more efficacious nerve block (as determined by results related to the primary objective).
Hypothesis 2: The QL block will be associated with shorter time to ambulation, time spent in the PACU, and length of stay. Because of requirements for the QL block to be administered preoperatively solely under ultrasound guidance by an anesthesiologist, receipt of the QL block is associated with increased operation time and total procedural costs compared to receipt of the TAP block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
By nature of the nerve block techniques, the patient, operating surgeon, and anesthesiologist will be aware of the assignments of individual participants. The statistician who will analyze the data will be blinded to the assignments.
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
- •Female ≥ 18 years of age at date of surgery
- •Patient is booked for a DIEP flap breast reconstruction. Immediate and delayed reconstruction are both acceptable. Unilateral and bilateral reconstruction are both acceptable.
- •English speaking or other with aid of in-person translator
排除标准
- •Patient unwilling to participate in trial
- •Patient has allergy to nerve block components
- •Patient is currently taking opioids for any reason
研究组 & 干预措施
TAP block
Participants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine.
干预措施: Surgeon-placed transversus abdominis plane block (Procedure)
QL block
Participants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine.
干预措施: Ultrasound-guided quadratus lumborum block (Procedure)
结局指标
主要结局
Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48
时间窗: Postoperative hour 0 to 48
Participants will be asked to self-report their pain using the Visual Analogue Scale (VAS) at postoperative hours 0, 2, 4, 6, 12, 24, 36, and 48. The minimum sore on the VAS is 0 (no pain) and the maximum score is 10 (worst pain).
Opioid consumption during the first 48 postoperative hours
时间窗: Postoperative hour 0 to 48
Participants' opioid consumption (in morphine milligram equivalents) during the first 48 postoperative hours will be recorded. (or until pt is discharged?)
次要结局
- Operation duration(Intraoperative period)
- Time spent in the post-anesthesia care unit(Postoperative - interval immediately following surgery)
- Length of hospital stay(Postoperative - approximately 48 hours)
- Time to ambulation(Postoperative hour 0 to 48)
- Costs associated with each intervention(Participant check-in to discharge, approximately 1 week)