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临床试验/CTRI/2018/05/013671
CTRI/2018/05/013671尚未招募不适用

Postoperative pain relief in arthroscopic shoulder surgery with ultrasound guided interscalene block with ropivacaine and fentanyl combination using two techniques- A prospective randomized controlled trial

Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Mean postoperative pain score measured by numeric rating scale(NRS) over 48h study period.

研究概览

简要总结

Regional anaesthesia has proven to be a highly effective technique for pain relief in patients undergoing total shoulder arthroplasty. Continuous Interscalene block for orthopaedic surgery may be used as either the primary anaesthetic  or as an adjunct to general anaesthesia. Shoulder surgeries are associated with substantial pain which may be exacerbated by shoulder movement on physiotherapy employed for postoperative rehabilitation and optimal surgical outcome. The benefit of effective continuous interscalene block include reductions in opoid requirements, reduced requirement for systemic analgesics, decrease postoperative nausea and vomiting, decreased time to functional recovery alongwith reduction in postoperative pain for prolonged period. So in this study we plan to compare the efficacy of ropivacaine (0.2%) and fentanyl (2 micrograms/ml) when used as perineural boluses of local anaesthetic delivered as on demand with continuous perineural infusion in interscalene block against only patient controlled boluses, along with intravenous dexamethasone (8 mg) as an adjunct in both groups after arthroscopic shoulder surgery.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-II BMI – 18-30 kg/m2 Undergoing Arthroscopic shoulder surgery such as rotator cuff injury repair, recurrent shoulder dislocations, superior labrum anterior and posterior (SLAP lesion), acromioplasty, labral cyst removal.

排除标准

  • Patient refusing to give informed consent History of relevant drug allergy History of psychiatric illness, substance abuse Severe cardiovascular, respiratory, metabolic or neurological disease Pregnancy and lactation Coagulopathy Contralateral phrenic nerve dysfunction Infection at planned injection site Patients on steroids.

结局指标

主要结局

Mean postoperative pain score measured by numeric rating scale(NRS) over 48h study period.

时间窗: Mean NRS pain score between the two groups over 48h study period at time intervals of 1,4,12,24,36,48h.

次要结局

  • Difference in total analgesic consumption, rescue analgesic use, manual muscle test scoring, patient satisfaction and adverse effects if any.

研究者

发起方
Department of Anaesthesia and Intensive Care
申办方类型
Government medical college

研究点 (1)

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