跳至主要内容
临床试验/CTRI/2024/08/072782
CTRI/2024/08/072782尚未招募4 期

Comparison of Ultrasound Guided Triple Injection Costoclavicular Block with Lateral Approach of Axillary Brachial Plexus Block in Below-Elbow Surgeries

Teerthanker Mahaveer Medical College and Research Centre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To compare the Sensory Motor Score for individual nerves in both the groups (Radial,Ulnar,Median,Musculocutaneous nerve).

研究概览

简要总结

After getting approval from Institutional Ethical Committee (IEC),those  patients who are fit in inclusion criteria will be included in our study and

After taking Written informed consent.

Randomization will be done  and 80 Patients will be assigned into two groups Group CC  and group AX.

Group CC (40,Costoclavicular approach) :  20‐mL 0.5% Ropivacaine.

Group AX (40,Axillary approach) : 20‐mL 0.5% Ropivacaine.

Patient will be shifted to Operating Room and after  following the standard protocol under strict aseptic precautions, ultrasound guided block will be performed with a 10‐cm, 21‐gauge nerve block needle and fixed dose of drug will be given.

The duration of procedure, Time of onset of sensory and motor block, duration of sensory and motor block, number of needle redirections and needle attempts will be noted.

The BPB will be considered incomplete if the composite score will be more than 16 points even after 30 min with sensory Grade - 0.In the event of an incomplete block after 30 min, a rescue block or local infiltration will be given and will be recorded as block failure .

Any complications of the block procedure such as hematoma, pneumothorax, and LA toxicity will be noted. Post operative sensory and motor block will be assessed at  1,2,4,6,8 hours

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Patient giving written and informed consent.
  • American Society of Anesthesiologist (ASA) physical status I-II.
  • Age group of 18-60 years old.
  • Elective below elbow surgery.
  • BMI 18.5-22.9kg/m2.

排除标准

  • Patients with coagulopathy Pre-existing neurological deficit Local infection.
  • Known allergic to local anesthesia.

结局指标

主要结局

To compare the Sensory Motor Score for individual nerves in both the groups (Radial,Ulnar,Median,Musculocutaneous nerve).

时间窗: The time immediately after LA injection will be considered as time 0mins for sensory and motor assessment. Every 5,10,15,20,25,30 min after block performance, assessed the sensory and motor block of Radial, Medial, Ulnar and Musculocutaneous nerve using Lovett score and duration will be 30 mins. | Post operative analgesia will be assessed in both groups after 1hr.2hr.3hr.4hr.5hr and then every 6th hourly.

To compare duration of post operative analgesia in both the groups.

时间窗: The time immediately after LA injection will be considered as time 0mins for sensory and motor assessment. Every 5,10,15,20,25,30 min after block performance, assessed the sensory and motor block of Radial, Medial, Ulnar and Musculocutaneous nerve using Lovett score and duration will be 30 mins. | Post operative analgesia will be assessed in both groups after 1hr.2hr.3hr.4hr.5hr and then every 6th hourly.

次要结局

  • To compare composite sensory motor block in both the groups.(To compare onset time in both the groups.)

研究者

发起方
Teerthanker Mahaveer Medical College and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Abishek Jain

TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD

研究点 (1)

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