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CTRI Number  CTRI/2025/01/079587 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   "Study on the Rate of Diaphragmatic Paralysis After Supraclavicular Brachial Plexus Block Using the Corner Pocket Technique" 
Scientific Title of Study   Incidence of hemi- diaphragmatic paralysis following supraclavicular brachial plexus block using corner pocket technique: A prospective observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dattatray Thombare 
Designation  Junior Resident ,Dept. of Anaesthesiology 
Affiliation  Lokmanya tilak Municipal Medical college and general Hospital 
Address  New College Building Lokmanya Tilak Municipal Medical college and General Hospital, Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8408892076  
Fax    
Email  datta.gt173@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti Kotwani 
Designation  Associate professor 
Affiliation  Lokmanya tilak Municipal Medical college and general Hospital 
Address  DEPT. OF ANAESTHESIOLOGY LTMMC & GH ,SION ,MUMBAI

Mumbai
MAHARASHTRA
400022
India 
Phone  9870135926  
Fax    
Email  drdeeptiagrawal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti Kotwani 
Designation  Associate professor 
Affiliation  Lokmanya tilak Municipal Medical college and general Hospital 
Address  DEPT. OF ANAESTHESIOLOGY LTMMC & GH ,SION ,MUMBAI

Mumbai
MAHARASHTRA
400022
India 
Phone  9870135926  
Fax    
Email  drdeeptiagrawal@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya tilak municipal medical college and general hospital, Sion, Mumbai, Maharashtra , india- 400022 
 
Primary Sponsor  
Name  LTMMC AND GH 
Address  Lokmanya tilak Municipal medical collage and general hospital ,sion,Mumbai ,400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DATTATRAY THOMBARE  Lokmanya Tilak Municipal Medical College and General Hospital, Sion , Mumbai  Dept of anaesthesiology, Ward and EMS building, Lokmanya Tilak Municipal Medical College and General Hospital, Sion , Mumbai
Mumbai
MAHARASHTRA 
8408892076

datta.gt173@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 years and above
2. American Society of Anesthesiology (ASA) physical status 1-3
3. Patient undergoing upper limb surgeries under ultrasound guided Supraclavicular block by corner pocket technique
4. Patients with no distal neurovascular deficit
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Infection at the puncture site/ distorted anatomy of the supraclavicular region / burns
3. Allergic to local anesthetic drugs
4. Coexisting acute or chronic pulmonary dysfunction
5. Coagulopathy
6. Pregnant patients
7. Contra-lateral diaphragmatic paralysis
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Percentage of cases with hemi Diaphragmatic paralysis after giving Supraclavicular block by Corner Pocket Technique  18 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.Effect of different volumes of Drugs on Outcome
2.Effect of using different Local Anaesthetic agent on Outcome 
18 MONTHS 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.
 
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