Regional Anesthesia for the Management of Perioperative Pain for Free Flap Reconstruction of the Head and Neck: A Randomized Prospective Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
- •Subjects undergoing primary reconstruction for both benign and malignant etiology
排除标准
- •Pregnant women
- •Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
- •Subjects undergoing reconstruction with more than 1 free flap
- •Subjects undergoing secondary reconstructions
- •Subjects undergoing surgery for osteonecrosis
- •History of enrollment in a pain management program
- •Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin
研究组 & 干预措施
Fibular free flap-Block performed
For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed
干预措施: Regional Anesthesia (Drug)
Anterolateral thigh free flap-Block performed
Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed
干预措施: Regional Anesthesia (Drug)
Radial forearm free flap-Block performed
Description: For subjects in the experimental/regional anesthesia group for anterolateral thigh or radial forearm free flap, during the procedure a catheter will be placed into the donor site (leg or arm), wound bed
干预措施: Regional Anesthesia (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 72 hours (3 days) post-operatively
Subjects' morphine equivalent dose. Postoperative period commences at extubation.
次要结局
未报告次要终点