跳至主要内容
临床试验/CTRI/2025/01/079587
CTRI/2025/01/079587尚未招募不适用

Incidence of hemi- diaphragmatic paralysis following supraclavicular brachial plexus block using corner pocket technique: A prospective observational study.

LTMMC AND GH1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年2月1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
78
试验地点
1
主要终点
Percentage of cases with hemi Diaphragmatic paralysis after giving Supraclavicular block by Corner Pocket Technique

研究概览

简要总结

Title: Ultrasound-guided Evaluation of Ipsilateral Hemi-Diaphragmatic Paralysis Following Supraclavicular Brachial Plexus Block Using the Corner Pocket Technique

Objectives:

  • Primary Objective: To calculate the incidence of ipsilateral hemi-diaphragmatic paralysis following the supraclavicular brachial plexus block using the Corner Pocket technique via ultrasound.
  • Secondary Objectives:
  • Investigate the effect of local anaesthetic volume and type (Ropivacaine vs. Bupivacaine) on HDP.
  • Assess operator satisfaction with diaphragm evaluation techniques.

Study Design: Prospective observational cohort study. The study will be conducted at Tertiary care Hospital, with a sample size of 78 patients.

Methods:

  • Patient Selection: Adults (18+ years) undergoing upper limb surgery with ultrasound-guided supraclavicular block via the Corner Pocket technique.

  • Exclusion Criteria: Conditions like acute/chronic pulmonary dysfunction, coagulopathy, or allergy to local anesthetics, among others.

  • Procedure: Diaphragmatic function will be assessed using ultrasound before the block, 20 minutes after the block, and at the end of surgery, focusing on diaphragmatic excursion and thickness via subcostal and intercostal approaches.

  • Diaphragmatic Excursion: Measured using M-mode ultrasound to assess movement during breathing. A reduction in diaphragmatic excursion (>75%) indicates complete paralysis, while a partial reduction (25-75%) indicates partial paralysis.

  • Diaphragmatic Thickness: Measured through intercostal windows. A reduction in the thickness change during deep breathing (≤5%) suggests complete paralysis, and a 5-20% change suggests partial paralysis.

Sample Size Calculation: Based on previous studies showing a 27.8% incidence of HDP with the CP technique, the sample size was calculated to be 78, allowing for a 10% margin of error and 95% confidence.

Results (Hypothesized):

  • The study hypothesizes that the incidence of hemi-diaphragmatic paralysis following the CP technique will be lower than previous reported figures (27.8%).
  • Additionally, the study will examine if the volume and type of local anaesthetic influence the likelihood of HDP.

Data Collection:

  • Baseline data (patient demographics, vitals) and block characteristics (LA used, success of block) will be noted.
  • Diaphragm measurements will be taken at three time points: pre-block, 20 minutes post-block, and at the end of surgery.
  • The success of the block will be assessed using sensory and motor testing, while HDP will be graded based on changes in diaphragmatic excursion and thickness.

Expected Contributions:

  • This study aims to provide evidence for the Corner Pocket technique’s effectiveness in minimizing diaphragmatic paralysis during supraclavicular BPB, offering a safer approach for patients with underlying respiratory conditions or other risk factors.
  • It will also compare two techniques for evaluating diaphragm function (subcostal vs. intercostal) to determine which offers the most reliable assessment.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above
  • American Society of Anesthesiology (ASA) physical status 1-3
  • Patient undergoing upper limb surgeries under ultrasound guided Supraclavicular block by corner pocket technique
  • Patients with no distal neurovascular deficit.

排除标准

  • Patient refusal
  • Infection at the puncture site/ distorted anatomy of the supraclavicular region / burns
  • Allergic to local anesthetic drugs
  • Coexisting acute or chronic pulmonary dysfunction
  • Coagulopathy
  • Pregnant patients
  • Contra-lateral diaphragmatic paralysis.

结局指标

主要结局

Percentage of cases with hemi Diaphragmatic paralysis after giving Supraclavicular block by Corner Pocket Technique

时间窗: 18 MONTHS

次要结局

  • 1.Effect of different volumes of Drugs on Outcome(2.Effect of using different Local Anaesthetic agent on Outcome)

研究者

发起方
LTMMC AND GH
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Dattatray Thombare

Lokmanya tilak Municipal Medical college and general Hospital

研究点 (1)

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