| CTRI Number |
CTRI/2025/03/081673 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of USG guided costoclavicular and supraclavicular brachial plexus block for forearm and hand surgeries: A Randomized Control Study |
|
Scientific Title of Study
|
A comparative study in term of surgical anaesthesia to evaulate the efficacy of costoclavicular block and supraclavicular block in patients undergoing forearm surgeries: a prospective randomized single blind 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. Shalini Sardesai |
| Designation |
Professor |
| Affiliation |
Smt. Kashibai navale medical college and general hospital, Narhe, Pune, 411041 |
| Address |
Department of Anaesthesiology and Critical Care, New Building- 3rd floor, Smt. Kashibai navale medical
college and general hospital, Narhe, Pune, 411041.
Pune
MAHARASHTRA
411041
India |
| Phone |
8699227140 |
| Fax |
|
| Email |
spsardesai.sp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Priyanka Shalu Kulkarni |
| Designation |
Professor |
| Affiliation |
Smt. Kashibai navale medical college and general hospital, Narhe, Pune, 411041 |
| Address |
Department of Anaesthesiology and Critical Care, New Building- 3rd floor, Smt. Kashibai navale medical
college and general hospital, Narhe, Pune, 411041.
Pune
MAHARASHTRA
411041
India |
| Phone |
8308468070 |
| Fax |
|
| Email |
drpriyankashalu85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dhiraj Chopra |
| Designation |
PG STUDENT |
| Affiliation |
Smt. Kashibai navale medical college and general hospital, Narhe, Pune, 411041 |
| Address |
Department of Anaesthesiology and Critical Care, New Building- 3rd floor, Smt. Kashibai navale medical
college and general hospital, Narhe, Pune, 411041.
Pune
MAHARASHTRA
411041
India |
| Phone |
8699227140 |
| Fax |
|
| Email |
dhirajchopra101@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Smt. Kashibai navale medical
college and general hospital, Narhe, Pune, 411041. |
|
|
Primary Sponsor
|
| Name |
Dr Dhiraj chopra |
| Address |
Department of Anaesthesiology and Critical Care, New Building- 3rd floor, Smt. Kashibai navale medical
college and general hospital, Narhe, Pune, 411041. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Priyanka Shalu Kulkarni |
Smt. Kashibai navale medical college and
hospital,Narhe,Pune, 411041. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalini Sardesai |
Smt. Kashibai navale medical college and general hospital, Narhe, Pune, 411041. |
Department of Anaesthesiology and Critical Care, New Building- 3rd floor
Pune
MAHARASHTRA |
9767190066
spsardesai.sp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt Kashibai Navale Medi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costo-clavicular block |
Inj. Lignocaine + adrenaline 2% 10ml + Inj. Bupivacaine 0.5% 10ml + Inj. Dexamethasone 4mg given during block administration |
| Comparator Agent |
Supra-clavicular block |
Inj. Lignocaine + adrenaline 2% 10ml + Inj. Bupivacaine 0.5% 10ml + Inj. Dexamethasone 4mg given during block administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Physical status ASA I and II patients
2) Patients scheduled for forearm and arm surgeries |
|
| ExclusionCriteria |
| Details |
Patients with:
1) Local site infection
2) Neuromuscular disease/nerve injury
3) Prior surgery on the infraclavicular and supraclavicular fossa
4) Pregnant patients
5) Contraindications to peripheral nerve blocks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the quality and overall efficacy of the both the study nerve blocks |
Assess the quality and overall efficacy of the both the study nerve blocks over 24 hours based on total analgesia time and rescue analgesic requirements |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess:
1) Haemodynamic parameters and complications |
1) Post-operativa analgesia
2) Requirement for rescue analesics in the first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Brachial plexus
block is a commonly used anaesthetic technique for upper extremity surgeries,
offering advantages over general anaesthesia, such as improved surgical anaesthesia
and reduced postoperative complications. Among the various approaches, the
costoclavicular brachial plexus block (CCB) is a newer method with potential
benefits over the traditional supraclavicular brachial plexus block (SCB). This
study aimed to compare the efficacy of these two approaches. |