| CTRI Number |
CTRI/2026/02/103278 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Patient came to the hospital for upper limb surgeries and we used Brachial plexus block using ultrasound guided retroclavicular approach in one group and ultrasound guided infraclavicular approach in another group |
|
Scientific Title of Study
|
Retroclavicular vs infraclavicular approaches for ultrasound guided brachial block A comparative analysis for upper limb surgeries |
| 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 Patel Arth Harshadbhai |
| Designation |
PG 1st year Resident |
| Affiliation |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of Anaesthesia Mahatma Gandhi Medical College Hospital Sitapur Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9067658689 |
| Fax |
|
| Email |
contact2arth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mangilal Deganwa |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of Anaesthesia Mahatma Gandhi Medical College Hospital Sitapur Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9871495240 |
| Fax |
|
| Email |
mangilaldeganwa0606@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mangilal Deganwa |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of Anaesthesia Mahatma Gandhi Medical College Hospital Sitapur Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
9871495240 |
| Fax |
|
| Email |
mangilaldeganwa0606@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College Hospital |
| Address |
Department of Anaesthesia Mahatma Gandhi Medical College Hospital Sitapur Jaipur India 302022 |
| 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 ARTH PATEL |
Mahatma Gandhi Medical College and Hospital |
Department of Anaesthesia 2nd floor OT complex Sitapura Jaipur 302022 Jaipur RAJASTHAN |
9067658689
contact2arth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECMGMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M848||Other disorders of continuity of bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular brachial plexus block |
Group B : receive Infraclavicularultrasound guided Brachial Plexus Block approach-0.5% Levobupivacaine15mL + Dexona(8mg) 2mL The total duration of procedure is until the requirement of first rescue analgesia or first 24 hours of surgery |
| Intervention |
Retroclavicular Brachial Plexus Block |
Group A : will receive Retroclavicular ultrasound guided Brachial plexus Block approach- 0.5% Levobupivacaine 18mL + Dexona (8mg) 2mL (total 20 ml)
The total duration of procedure is until the requirement of first rescue analgesia or first 24 hours of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ASA grade I/II
2. Elective upper limb surgeries (elbow, forearm and hand surgeries) |
|
| ExclusionCriteria |
| Details |
1 Any bleeding disorder or patient on anticoagulants.
2. Neurological deficits involving brachial plexus.
3. History of drug allergy.
.4 Local infection at the injection site.
.5 Patients on any sedatives or antipsychotics.
6. History of alcohol and drug abuse.
7. Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare time taken from needle entry to installation of drug.
2. To compare the time of drug deposition ot complete blockade. |
Motor blockade scale at 0,5,10,15,20,25,30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study complications associated with either technique.
2. To study the conversion to general anaesthesia.
3. To study the need for rescue analgesia |
Motor blockade scale at 0,5,10,15,20,25,30 mins. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="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
|
Peripheral nerve block is always a safe alternative to general anaesthesia. Patient remains awake oriented and with intact airway reflexes throughout the procedure. In addition it offers a better preservation of mental functions in elderly decreased risk of aspiration due to intact pharyngeal and laryngeal reflexes avoids difficult intubation decreases postoperative complications associated with intubation and provide better postoperative analgesia without undue sedation facilitating early mobilization and discharge. Brachial Plexus block is administered by various approaches viz. supraclavicular infraclavicular interscalenous perivascular subclavian and axillary routes for upper limb surgeries. The Infraclavicular block is achieved by injecting local anesthetic around the cords of the brachial plexus which are located in the infraclavicular fossa. It’s commonly used for procedures on the elbow, forearm, wrist, and hand, especially when other approaches like the axillary block are difficult due to patient positioning or other factors. Compared to other brachial plexus blocks the infraclavicular approach may offer better coverage of the upper arm and easier catheter placement for continuous nerve blocks. It also avoids some of the respiratory complications associated with supraclavicular and interscalene blocks. The retroclavicular refers to the needle insertion point, which is posterior and deep to the clavicle rather than directly under it as in some other infraclavicular approaches.The patient is typically positioned supine with their head turned away from the side being blocked and a bump under their back to depress the shoulder and clavicle.The needle is inserted 1-2 cm posterior to the clavicle in the supraclavicular fossa kept parallel to the floor.The needle is advanced until it contacts the clavicle then walked off its undersurface, and hydrodissection is used to create space around the posterior cord and artery before injecting the local anesthetic. Retroclavicular approach provides better needle visualization and lesser time for administration of brachial plexus block. Lesser chances of block related complication. |