| 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" |
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Scientific Title of Study
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, |
|
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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
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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 |
|
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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 TechniqueObjectives: - 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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