| CTRI Number |
CTRI/2024/11/076223 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The aim is to compare how well an ultrasound-guided costoclavicular brachial plexus block works when using either 25 ml or 20 ml of 0.5 percent bupivacaine in adult patients undergoing upper limb surgeries.
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Scientific Title of Study
|
Comparison of efficacy of ultrasound guided costoclavicular brachial plexus blockade with 25ml and 20ml of 0.5 percent Bupivacaine |
| 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 Rahul Kumar |
| Designation |
PG Resident |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL, NEW DELHI-110029 |
| Address |
Department of Anaesthesia and Intensive Care,ground floor,main operation theater building,Safdarjung Hospital campus,Ansari Nagar East,New Delhi,Delhi,110029,India
South
DELHI
110029
India |
| Phone |
8920495544 |
| Fax |
|
| Email |
rahuljinnl98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAJPAL SINGH |
| Designation |
Professor and Consultant |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL NEW DELHI-110029 |
| Address |
Department of Anaesthesia and Intensive Care,ground floor,main operation theater building,Safdarjung Hospital campus,Ansari Nagar East,New Delhi,Delhi,110029,India
South
DELHI
110029
India |
| Phone |
9911858311 |
| Fax |
|
| Email |
Doctorrajpal04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Kumar |
| Designation |
PG Resident |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL, NEW DELHI-110029 |
| Address |
Department of Anaesthesia and Intensive Care,ground floor main,operation theater building,Safdarjung Hospital campus,Ansari Nagar East,New Delhi,Delhi,110029
South
DELHI
110029
India |
| Phone |
8920495544 |
| Fax |
|
| Email |
rahuljinnl98@gmail.com |
|
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Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi , India, 110029 |
|
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Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi 110029 |
| Address |
Department of Anaesthesia and Intensive Care, ground floor,main operation theater building, Safdarjung Hospital campus, Ansari Nagar east, New Delhi, Delhi, 110029 , India |
| 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 Rahul Kumar |
Vmmc and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care ground floor main operation theater building Safdarjung Hospital campus Ansari Nagar east New Delhi Delhi 110029
South West
DELHI |
8920495544
rahuljinnl98@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Vardhman Mahavir Medical College and Safdarjung Hospital |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costoclavicular block with 20ml vs 25 ml of 0.5 percent Bupivacaine. |
1.Positioning: The patient will be supine with the head tilted to the opposite side and the operative arm abducted to 90 degrees.
2. Preparation: Clean and drape the infraclavicular area. Use a high-frequency linear ultrasound transducer to visualize the costoclavicular area and identify the axillary artery and the three cords of the brachial plexus.
3.Needle Insertion: After skin infiltration with 2% lignocaine, insert a 22G 50 mm short bevel needle using an in-plane technique, advancing it to position the tip in the middle of the three cords. Confirm the position with 0.5-1 ml normal saline before injecting the local anesthetic.
4. Local Anesthetic Injection:
Group L: 20 ml of 0.5% Bupivacaine
Group H: 25 ml of 0.5% Bupivacaine
- Record the time of the block.
5. Block Assessment:
Sensory Blockade: Graded 0 (no block), 1 (analgesia), or 2 (anaesthesia) using a cold test on specific areas for each nerve.
Motor Blockade: Graded 0 (no block), 1 (paresis), or 2 (paralysis) based on muscle function for each nerve.
6. Success Criteria:
- A block is considered successful if the composite score is ≥14 points with a sensory score of ≥7 out of 8.
- The onset time is the time required to achieve a composite score of ≥14 points.
7. Failure and Management:
- If the score is 14 points after 30 minutes, the patient will proceed to surgery with possible use of intravenous opioids, general anesthesia, or additional local anesthetic by the surgeon.
- Document any side effects or complications related to the block.
This approach ensures that the blocks effectiveness is carefully monitored and provides clear criteria for success and failure. |
| Comparator Agent |
Costoclavicular brachial plexus block with 20ml vs 25ml of 0.5 percent Bupivacaine
|
post operatively the time for first analgesic requirement and total analgesic consumption in the first 24 hours will also be recorded. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adults posted for surgeries of elbow, forearm, wrist and hand of ASA Grade 1/II between age group of 18 to 65 years of either sex. |
|
| ExclusionCriteria |
| Details |
1)Sepsis or infection at the injection site
2) Pre-existing peripheral neuropathy or coagulation disorders
3)Known allergy to local anesthetic drugs
4) BMI greater than 30 kg/m² |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the block onset time after ultrasound guided costoclavicular block with 25ml and 20ml of 0.5% bupivacaine in adult patients undergoing distal upper limb surgeries.
|
Block assessment will be done every 3 minutes after injection of LA till 30 minutes |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the Duration of analgesia
2. To compare the motor block between both the groups according to modified Bromage.
scale
3. To compare 24 hours analgesia requirement between both the groups |
The time for 1st analgesia requirement and total analgesic consumption in the first 24 hrs will be recorded.
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
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Brief Summary
|
The costoclavicular block, introduced by Karmakar et al., targets the brachial plexus in the costoclavicular space, where the plexus is superficial and arranged in a triangular configuration lateral to the axillary artery. This anatomical setup makes it a promising site for ultrasound-guided blocks.
A study on ultrasound-guided costoclavicular blocks with 0.5% ropivacaine found that 19 ml of the solution is typically effective for achieving surgical anesthesia in 95% of patients. However, similar research on 0.5% bupivacaine is lacking. There is limited literature assessing whether 20 ml of 0.5% bupivacaine provides comparable efficacy to 25 ml of the same concentration for upper limb surgeries when using the costoclavicular approach.
The main aim of the study is to compare the efficacy of ultrasound guided costoclavicular brachial plexus blockade with 25ml and 20ml of 0.5% bupivacaine in adult patients and the main objective is to compare the block onset time after ultrasound guided costoclavicular block with 25ml and 20ml of 0.5% bupivacaine in adult patients undergoing distal upper limb surgeries. |