跳至主要内容
临床试验/CTRI/2022/06/043115
CTRI/2022/06/043115尚未招募不适用

Comparison of infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries: A Randomised Control Trial

KIng George medical university1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
试验地点
1
主要终点
To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours.

研究概览

简要总结

Aim:

To compare the efficacy of infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia for shoulder surgery .

Primary Objectives:

To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours.

Secondary Objectives:

  1. To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries in terms of patient satisfaction.

  2. To compare the use of other analgesics in post operative period in infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block with suprascapular nerve block for shoulder surgeries.

Study settings:

MATERIAL AND METHODS

The study will be conducted in Department of Anaesthesiology, King George’s Medical University, Lucknow

Study duration:

One year

Study design:

Single blind,Hospital based,Prospective Randomized controlled study Sample Size: 31 in each group.

Inclusion Criteria:

Patients of either sex, aged 18-65 years.

Patients giving written informed consent will be taken.

ASA Grade I, II and III Shoulder Surgeries

Exclusion criteria

morbid obesity

pregnancy

Allergy

Patients not giving consent

Coagulopathy

Local site infections

Methodology:

The study will be conducted after getting approval from ethics committee of King Georges Medical University, Lucknow after taking patient’s consent. The patients will be randomly allocated in either of the two groups after fulfilling the inclusion criteria mentioned above using opaque sealed envelope technique. The groups are as follows,

STUDY GROUPS

• Group-A : brachial plexus block using infraclavicular approach for Shoulder Surgeries

• Group-B : brachial plexus block using infraclavicular approach in combination with suprascapular nerve block for Shoulder Surgeries.

STUDY PROTOCOL

The study will be conducted in a single blind manner where the participants will be blinded to the study. Written and informed consent will be taken from all participants. On the evening before surgery,routine pre-anaesthetic checkup will be done in all patients. Upon arrival to the operating room,routine monitoring including electrocardiography,pulse oximetry and blood pressure monitoring will be done. Part preparation will be done and infraclavicular brachial plexus block and combined infraclavicular Brachial plexus block with suprascapular nerve block will be given according to allocation of the patients in each group under all aseptic conditions.

The patients will be monitored for post operative analgesia for a duration of 24 hours at intervals of 1,3,6,12,24 hours using Visual Analogue Scale(VAS SCALE).

Patient satisfaction and use of other analgesics in post operative period will also be compared alongside.

研究设计

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

  • Patients of either sex, aged 18-65 years.
  • Patients giving written informed consent will be taken.
  • ASA Grade I, II and III Shoulder Surgeries.

排除标准

  • morbid obesity pregnancy Allergy Patients not giving consent Coagulopathy Local site infections.

结局指标

主要结局

To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours.

时间窗: 3 months

次要结局

  • 1. To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries in terms of patient satisfaction.(2. To compare the use of other analgesics in post operative period in infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block with suprascapular nerve block for shoulder surgeries.)

研究者

申办方类型
Government medical college

研究点 (1)

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