Comparison of Suprainguinal Fascia Iliac Block With and Without Dexmedetomidine as an Adjunct to Ropivacaine for Postoperative Analgesia Following Hip Surgery: a Randomized, Double-blinded Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time of administration of first analgesic after the surgery
研究概览
简要总结
The investigators are evaluating postoperative outcomes in patients undergoing hip replacement surgery performed with either spinal or general anesthesia, who also receive a suprainguinal fascia iliaca block using either perineural ropivacaine alone or ropivacaine combined with dexmedetomidine.
详细描述
Patients undergoing hip replacement surgery often receive a single-shot suprainguinal fascia iliaca block as a part of the primary anesthetic and multimodal postoperative analgesic strategy. However, the analgesic effect of a single-shot block typically diminishes after several hours and may be inconsistent beyond 24 hours. Adding dexmedetomidine, an alpha-2 agonist, to the local anesthetic has been shown to prolong block duration and reduce postoperative opioid requirements. Investigating its use in suprainguinal fascia iliaca blocks for total hip arthroplasty may clarify its clinical effectiveness. The investigators hypothesize that patients receiving ropivacaine with dexmedetomidine will have a significantly longer time to first analgesic request compared to those receiving ropivacaine alone.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective total hip arthroplasty
- •18-80 years old
- •ASA 1-3 classifications
排除标准
- •ASA classification of 4 or greater
- •Infection at the site of nerve blockade
- •Coagulopathy
- •Known allergy to study medications
- •Chronic opioid consumption (>3 months)
- •Currently using lidocaine patches
- •Pre-existing neuropathy
- •A history of CVA
- •High grade atrioventricular block (cardiac conduction system impairment)
- •Organ dysfunction (cardiac failure, respiratory failure, end stage renal disease, hepatic dysfunction, hypoalbuminemia)
- •Morbid obesity (≥40 kg/m2)
- •Prior surgery in supra and/or infrainguinal region
- •Non-English-speaking participants
研究组 & 干预措施
Ropivacaine
30 ml of 0.25% ropivacaine; No dexmedetomidine
干预措施: Ropivacaine (Drug)
Ropivacaine plus Dexmedetomidine
30 ml of 0.25% ropivacaine; 1 mcg/kg of dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Ropivacaine plus Dexmedetomidine
30 ml of 0.25% ropivacaine; 1 mcg/kg of dexmedetomidine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Time of administration of first analgesic after the surgery
时间窗: Time to first analgesic request, defined as the interval (in minutes) from block administration to the first request for rescue analgesia, assessed for up to 24 hours.
次要结局
- Total opioid consumption (converted to morphine milligram equivalents)(From the start of surgery through 48 hours postoperatively)
- Quality of Recovery(24 hours)
- Pain Scores(Up to two hours [post anesthesia recovery unit], 6 hours, 12 hours, 24 hours and 48 hours after surgery)
研究者
Vendhan Ramanujam
Principal Investigator
Rhode Island Hospital