| CTRI Number |
CTRI/2025/12/098651 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of two approaches of brachial plexus block- costoclavicular and supraclavicular brachial plexus block- in patients undergoing upperlimb surgeries |
|
Scientific Title of Study
|
A comparative study of ultrasound guided costoclavicular versus supraclavicular brachial plexus block in patients undergoing upperlimb surgery. |
| 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 Geetha CR |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Second floor, MS Ramaiah Medical College,
New BEL Road, Bangalore - 560054
Bangalore, KARNATAKA
Bangalore KARNATAKA 560054 India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Geetha CR |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Second floor, MS Ramaiah Medical College,
New BEL Road, Bangalore - 560054
Bangalore, KARNATAKA
Bangalore KARNATAKA 560054 India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geetha CR |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Second floor, MS Ramaiah Medical College,
New BEL Road, Bangalore - 560054
Bangalore, KARNATAKA
Bangalore KARNATAKA 560054 India |
| Phone |
9900482828 |
| Fax |
|
| Email |
jageedha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah medical college ,New BEL Road, MSRIT Post, Bangalore – 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah medical college |
| Address |
New BEL Road, MSRIT Post, Bangalore – 560054 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Prakruthi RV |
MS Ramaiah Medical College |
Department of Anaesthesiology,Second floor, MS Ramaiah Medical College,New BEL Road, Bangalore - 560054Bangalore, KARNATAKA Bangalore KARNATAKA |
6360070245
Prakruthirv08@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah medical college Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
To compare the efficacy of supraclavicular and costoclavicular brachial plexus block in patients undergoing upper limb surgeries |
To compare the costoclavicular and supraclavicular approach of brachial plexus with respect to onset of sensory and motor blockade.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged between 18 to 65 years posted for elective upperlimb surgeries.
2) American Society of Anaesthesiologists (ASA) physical status 1and 2
|
|
| ExclusionCriteria |
| Details |
1) Pre-existing pulmonary pathologies.
2) Pre-existing known neuropathy concerning the forearm present surgery.
3) Infection on the needle insertion site.
4) Coagulopathies.
5) Pregnancy.
6) Body mass index more than 30kg/m2.
7) Allergy to local anaesthetics.
|
|
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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
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the onset of complete sensory and motor blockade at after LA injection. |
. The sensory blockade of the four nerves will be evaluated and graded every 3 mins until 30 mins after injection by double blinded observers using a 3 point scale (0 = no block , 1 = analgesia i.e patient can feel touch but not cold, 2 = anaesthesia i.e patient cannot feel touch). Motor blockade will be tested and graded according to a 3 point scale ( 0 = no block, 1 = paresis, 2 = paralysis). Motor blockade of each nerve will be evaluated by elbow flexion for (MCN), wrist flexion for (MN), wrist extension for (RN), flexion and opposition of fifth finger towards the thumb for (UN).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the performance time, number of needle passess and duration of analgesia between the two techniques.
To assess the incidence of complications such as hemidiaphragmatic dysfunction, pneumothorax, Horners syndrome and vessel puncture.
To assess the incidence of block failure or rescue analgesia.
|
VAS score will be assessed to elicit the duration of post operative analgesia at predetermined time intervals 0th (at the onset of sensory blockade), 2, 4, 6, 12, 18, 24th hour. To assess the incidence of diaphragmatic dysfunction,anaesthesiologist will perform repeat ultrasound within 1 hour of the patient’s arrival in the recovery room after the surgery. |
|
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Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
01/01/2026 |
| 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="2" Months="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Prakruthirv08@gamil.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
One of the most popular methods of administering anaesthesia and pain releif for upper limb surgery is a regional brachial plexus block. Brachial plexus can be blocked by supraclavicular, infraclavicular, costoclavicular, axillary and interscalene approaches.
The use of ultrasound in these blocks enhances the success rates and reduces complications significantly. It improves the visualisation of nerve bundles, enables real time assessment of needle placement and this has lead to reduction in the total volume of anaesthetic drugs required. It also helps in avoiding crucial structures such as pleura, blood vessels and enhances the precision of the local anaesthesic drug infiltration along the targeted nerves.
Supraclavicular brachial plexus block(SCBPB) is often called the spinal anaesthesia of the arm, due to its rapid onset of blockade. For the supraclavicular (SC) approach, the trunk and divisions of the brachial plexus are arranged compactly superolaterally around the subclavian artery at the supraclavicular fossa. However, complications such as hemidiaphragmatic paralysis due to phrenic nerve blockade, Horner’s syndrome due to sympathetic nerve block and pneumothorax may occur.
Costoclavicular approach of BPB is a modification of ultrasound guided infraclavicular approach of BPB. Under ultrasound guidance, the costoclavicular space (CCS) is visualised as a well defined intermuscular space , lying deep and posterior to midpoint of clavicle. It is located between the clavicular head of pectoralis major and subclavius muscle anteriorly and the upper slips of serrtus anterior muscle and second rib posteriorly. All 3 cords of brachial plexus are more superficial and visualized in a single transverse sonogram of CCS as the cords are clustered together lateral to axillary artery. Therefore a a low dose of LA(local anaesthetic) and single injection would provide more effective blockade. Block needle can be easily directed to the centre of the plexus with minimal discomfort to patient.
The danger of vascular puncture and pleural puncture is minimized with costoclavicular approach as the nerve cords are first approached before vessel and the pleura. |