| CTRI Number |
CTRI/2025/02/080124 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different types of regional anesthesia given using ultrasound for forearm and hand surgeries |
|
Scientific Title of Study
|
Comparison of ultrasound guided costoclavicular brachial plexus block versus supraclavicular brachial plexus block for forearm and hand surgeries: A double blinded randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumar Arun |
| Designation |
Resident Anesthesiology |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology and Critical Care
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9599796279 |
| Fax |
|
| Email |
a12061988k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brig Rahul Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology and Critical Care
Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr John Magesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology and Critical Care
Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9765167438 |
| Fax |
|
| Email |
majjohnmk9090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College,Pune, Maharashtra 411040 |
|
|
Primary Sponsor
|
| Name |
Kumar Arun |
| Address |
Department of Anaesthesiology and Critical Care Armed Forces Medical College
Pune 411040 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kumar Arun |
Command Hospital/Military Hospital (Armed forces medical College) |
OT Complex,Pune, Maharashtra, 411040
Pune
MAHARASHTRA |
09599796279
a12061988k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell and Institutional Ethical Committee Armed Forces Medical College Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Costoclavicular brachial plexus block |
Costoclavicular brachial plexus block-Under ultrasound guidance 20 ml of 0.5% Injection Bupivacaine with 4mg Dexamethasone will be injected in costoclavicular space in one group. |
| Intervention |
Costoclavicular brachial plexus block versus Supraclavicular brachial plexus block |
Costoclavicular brachial plexus block-Under ultrasound guidance 20 ml of 0.5% Injection Bupivacaine with 4mg Dexamethasone will be injected in costoclavicular space in one group.
Supraclavicular brachial plexus block (in other group)- ultrasound guidance 20 ml Injection Bupivacaine with 4mg Dexamethasone will be injected around subclavian artery |
| Comparator Agent |
Supraclavicular brachial plexus block |
Supraclavicular brachial plexus block (in other group)- ultrasound guidance 20 ml Injection Bupivacaine with 4mg Dexamethasone will be injected around subclavian artery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective forearm and hand surgeries
2. American Society of Anaesthesiologists physical status I, II & III
3.Willing to provide informed consent for participation in the study |
|
| ExclusionCriteria |
| Details |
Known allergy or contraindication to local anesthetics.
Pre-existing neurological deficits in the upper limb.
Coagulopathy or bleeding disorders.
Significant cardiopulmonary, hepatic or renal diseases.
History of chronic pain syndromes or psychiatric disorders.
Inability to lie in a suitable position for the regional anesthesia procedure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the onset of sensory and motor blockade |
After 5 minutes of performing procedure and then every 5 minutes of interval till complete blockade is achieved |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the duration of performance of block, duration of analgesia, nerve sparing effects, overall success rates and adverse events |
Postoperatively, pain score (Visual analogue scale) will be recorded at 0,2,4.6.12 and 24th hour. |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 2 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="0" |
|
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
|
Regional anesthesia involves injecting drug directly to the peripheral nerves to block pain and movements in surgical site, without affecting patient’s consciousness, it minimizes systemic side effects in comparison to general anesthesia. Supraclavicular and infraclavicular brachial plexus block are common regional anesthesia techniques used for upper limb surgery. Costoclavicular brachial plexus block is a modification of ultrasound guided infraclavicular technique. Ultrasound guidance enhances safety as it allows precise visualization of nerves and hence provides faster onset. Our hypothesis is that Costoclavicular brachial plexus block will cause rapid onset of nerve blockade compared to Supraclavicular brachial plexus block. Factors such as onset of sensory and motor blocks, nerve sparing, procedural duration and duration of analgesia will be compared within the two groups.
|