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临床试验/CTRI/2023/08/056862
CTRI/2023/08/056862尚未招募2/3 期

A randomized controlled trial to study effectiveness of nalbuphine vs dexmedetomidine as an adjuvant to local anaesthesia in patients undergoing Upper limb surgeries under ultrasound guided supraclavicular block.

DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CAREINSTITUTE OF NAVAL MEDICINE INHS ASVINI1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年3月9日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
To compare:-

研究概览

简要总结

The study is randomized double blind, parallel group control trial.

The selected patients will be divided into three groups of 32 patients in each group. Group A: Receives ropivacaine plain 0.5 % 10 ml +lignocaine plain 2 % 5 ml +10ml Normal saline (NS), Group B: Receives ropivacaine plain 0.5 % 10 ml +lignocaine plain 2 % 5 ml + 50 microgram dexmedetomidine diluted in 10 ml NS ,Group C: Receive ropivacaine plain 0.2 % 10 ml +lignocaine plain 2 % 5 ml + Nalpbuphine 10 mg diluted in 10 ml NS.

On the morning of surgery computer generated randomization will be conducted and patient will be given local anaesthetic solution as per randomization. The local anaesthetic solution, with or without adjuvant, will be prepared by a different anaesthesiologist. Thus, the team giving brachial plexus block will be unaware of the local anaesthetic solution used, with or without adjuvant. Patient will also be unaware of the local anaesthetic solution, with or without adjuvant used for the block.

Sensory and motor assessment will performed immediately after positioning the patient supine and every 5 minutes to check for onset of sensory and motor blockade.

In the post operative period, Basal hemodynamics (HR, NIBP) and NRS score for pain, SpO2, sensory and motor weakness, requirement of rescue analgesia, nausea, vomiting will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours. Any other complications will also be noted.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • •ASA Grade I & II Patient undergoing upper limb orthopaedic surgeries.

排除标准

  • •1.Patients are unwilling 2.Patients with bleeding disorders, 3.Patients on anticoagulants, 4.Patients with neurological and musculoskeletal disease, 5.Infection at the site of injection 6.History of allergy to local anaesthetics.

结局指标

主要结局

To compare:-

时间窗: (a)Immediately after positioning the patient supine and every 5 minutes to check for onset of sensory and motor blockade | (b)In the post operative period NRS score for pain, SpO2, sensory and motor weakness, requirement of rescue analgesia, will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours.

(a)The onset of sensory and motor blockade.

时间窗: (a)Immediately after positioning the patient supine and every 5 minutes to check for onset of sensory and motor blockade | (b)In the post operative period NRS score for pain, SpO2, sensory and motor weakness, requirement of rescue analgesia, will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours.

(b)The duration of sensory and motor blockade.

时间窗: (a)Immediately after positioning the patient supine and every 5 minutes to check for onset of sensory and motor blockade | (b)In the post operative period NRS score for pain, SpO2, sensory and motor weakness, requirement of rescue analgesia, will be noted during following intervals: 0-2 hours, 4-6 hours, 6-12 hours, 12-24 hours.

次要结局

  • Intraop & post op side effects & complications

研究者

发起方
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CAREINSTITUTE OF NAVAL MEDICINE INHS ASVINI
申办方类型
Other [self]

研究点 (1)

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