跳至主要内容
临床试验/CTRI/2022/03/041352
CTRI/2022/03/041352尚未招募不适用

A prospective randomised interventional study for success of USG guided supraclavicular block by single-point versus multiple-point Injection technique at SMS medical college, Jaipur during 2021-2023

Sawai Mansingh Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2022年1月4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
204
试验地点
1
主要终点
Difference in proportion of success rate (i.e., nerve sparing) and mean of time taken to perform procedures

研究概览

简要总结

Patient satisfying inclusion criteria will be selected and taken in OT

Patient identity will be confirmed, PAC will be done and informed written consent will be checked.

Noninvasive monitors (NIBP,Pulse oximeter,ECG) will be monitored and ringer lactate will be started intravenously

Patient will lie in supine position, with the head turned to the opposite side. Under all aseptic precautions, ultrasound guided supraclavicular brachial plexus block will be performed after explaining the procedure in each group. Using sonosite micromaxx high frequency linear probe

Group A (n=102) USG guided singlepoint injection supraclavicularblock given by injecting 15ml of 0.5% Ropivacaine

Group B(n=102) USG guided multiple point injection supraclavicular block given by injecting 15ml 0.5% Ropivacaine

Here, time required to complete the procedure in each group will be recorded

Patients will be evaluated for onset of sensory and motor block every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic . Sensory blockade will be assessed by Pin Prick and Cold Test. Motor block will be assessed by asking the patient to move elbow, wrist and fingers.

Sparing of nerves will be noted and supplemented. The onset times of sensory and motor block will be noted.

Once the patient will achieve sensory block of grade 2 then surgeons

will be asked to proceed. Injection Midazolam 0.02mg/kg will be given to every patient for his/her comfort.

Hemodynamic parameters (Heart rate, NIBP and SPO2) will be monitored every 5 minutes for the first half an hour and thereafter every 15 minutes

administration of postoperative analgesic (Inj. Diclofenac 75 mg IV) and Inj. Tramadol 100 mg IV

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing surgical procedure on upper limb of duration 1-4 hours.
  • Patients of either gender of Age group of 18 to 60 year.
  • ASA grade I -III.
  • BMI OF 18-30 kg/m2.

排除标准

  • Exclusion Criteria:
  • Patients not willing to participate in study and uncooperative patients.
  • Coagulopathies, any neuropathy.
  • Allergy to LA (Ropivacaine)
  • Local pathology at the injection site
  • Disability limiting the performance of block.

结局指标

主要结局

Difference in proportion of success rate (i.e., nerve sparing) and mean of time taken to perform procedures

时间窗: 1. Evaluation of nerves assessment by every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic . | 2. Time taken to perform procedures in minutes

次要结局

  • Mean onset of sensory and motor block(Evaluation of nerves assessment by every 2 minutes for first 10 minutes and later 5 minutes till half an hour after completion of injection of local anesthetic .)

研究者

发起方
Sawai Mansingh Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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