Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Patient-perceived Duration of Analgesia
研究概览
简要总结
For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.
Depending on the randomized treatment assignment, patients may receive one of the following:
- 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
- 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
- 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.
Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.
- •ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]
- •BMI < 35
- •Smokers included
- •Ages 16-65
排除标准
- •Patients on steroids or requiring stress dose steroids
- •BMI > 35
- •Patient refusal
- •Allergy to study medications,
- •NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks
- •Lower extremity neurological dysfunction
- •Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)
- •Not in included age range (under 16 or over 65 years of age)
- •Contraindications to the use of dexamethasone
- •Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).
研究组 & 干预措施
Control
干预措施: Bupivacaine Only (Drug)
Dexamethasone 1 mg
干预措施: Bupivacaine with 1 mg of Dexamethasone (Drug)
Dexamethasone 4 mg
干预措施: Bupivacaine with 4 mg of Dexamethasone (Drug)
结局指标
主要结局
Patient-perceived Duration of Analgesia
时间窗: Up to 2 days following surgery
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
次要结局
- NRS (Numerical Rating Scale) Pain Scores(Postoperative day 1)
- Patient Satisfaction(Up to 2 days following surgery)
- Postoperative Morphine Consumption(Up to 2 days following surgery)
- Opioid-Related Side Effects (Drowsiness)(Up to 2 days following surgery)