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临床试验/CTRI/2025/05/086169
CTRI/2025/05/086169尚未招募4 期

Comparison of different doses of Butorphanol as adjuvant with Ropivacaine for single shot Adductor canal block in knee Arthroscopic surgery

Swami Rama Himalayan University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
75
试验地点
1
主要终点
Assessment of duration of analgesia detected by the first analgesia rescue dose and total analgesic consumption

研究概览

简要总结

AIMS AND OBJECTIVES

1- To evaluate the post operative analgesic efficacy of two different doses of butorphanol using NRS pain scoring system in USG guided adductor canal block in knee arthroscopic surgery .

2- To compare total post operative analgesic consumption among the three groups.

3- To compare the incidence of adverse effects and complications if any.

4-To evaluate patient satisfaction using QR15 score .

BRIEF SUMMARY

Arthroscopy (also called arthroscopic or keyhole surgery) is a minimally invasive surgical procedure on a joint in which an examination and  treatment of damage is performed using an arthroscope, an endoscope that is inserted into the joint through a small incision. Arthroscopic procedures can be performed during ACL reconstruction. This reduces recovery time and may increase the rate of success due to less trauma to the connective tissue. It has gained popularity due to evidence of faster recovery times with less scarring, because of the smaller incisions.

Arthroscopic knee  surgery is accompanied with considerable postoperative pain. Early postoperative mobilization and rehabilitation require adequate pain management of the patient . Despite the fact that femoral nerve block (FNB) or continuous epidural anesthesia (CEA) can provide adequate postoperative pain control, both treatments have negative side effects such as muscle weakness, delayed recovery which can delay postoperative mobilization .

The adductor canal block (ACB) is a relatively newer  analgesic block for knee arthroscopic surgery that not only blocks the femoral nerve’s largest sensory branch, but also causes a smaller decrease in quadriceps muscle strength in adult patients than the femoral nerve block (FNB)

ACB provides analgesia equivalent to FNB ,also  preserves quadriceps muscular strength better than FNB, and so allows for functional recovery within the first day after arthroscopic knee surgery according to randomized controlled trials.

The primary outcome is the assessment of duration of analgesia detected by the first analgesia rescue dose and total analgesic consumption.

Secondary outcomes includes the impact of single-shot adductor canal block using ropivacaine and butorphanol on postoperative recovery by patient  outcome assessment ,  sedation, and the side effects that could occur in the 24-hour study period in patients undertaking total knee arthroscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1- patient aged 18 to 60 years 2- ASA Grade 1 and 2 3- consent for regional anaesthesia.

排除标准

  • 1-ASA III and IV 2-Refusal or contraindication for regional anaesthesia 3-Known allergy to local anaesthesia 4-Bleeding disorder 5-Patient on anticoagulant medications 6-Infection at local site 7-Significant cardiac disease, renal failure, Asthma 8-Patient with psychiatric disorder or inability to operate PCA pump 9- Body mass index more than 30 kilogram per metre square of height.

结局指标

主要结局

Assessment of duration of analgesia detected by the first analgesia rescue dose and total analgesic consumption

时间窗: first analgesia rescue dose and total analgesic consumption

次要结局

  • The impact of single shot adductor canal blovk using ropivacaine and butorphanol on postoperative recovery(Patient outcome assessment , sedation , and the side effects that could occur in yhr 24 hour study period in patients undertaking tptal knee arhtroscopu)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Mohit Kandari

Himalayan Institute of Medical Sciences, SRHU Dehradun

研究点 (1)

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