| CTRI Number |
CTRI/2018/09/015723 [Registered on: 14/09/2018] Trial Registered Prospectively |
| Last Modified On: |
22/02/2021 |
| 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 methods of giving local anaesthesia for operations on the upper limb |
|
Scientific Title of Study
|
A Randomized Controlled Study Comparing Supraclavicular and Infraclavicular Approaches to Brachial Plexus Block under Ultrasound Guidance for Upper limb Procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharanya |
| Designation |
Junior Resident |
| Affiliation |
Sree Balaji Medical College |
| Address |
Department of Anesthesia, Pain Clinic and Critical Care, Sree Balaji Medical College, No 7 CLC Works road, Chrompet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
7550249469 |
| Fax |
|
| Email |
sharanya.sharanya.p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Ajaykumar |
| Designation |
Professor |
| Affiliation |
Sree Balaji Medical College |
| Address |
Department of Anesthesia, Pain Clinic and Critical Care, Sree Balaji Medical College, No 7 CLC Works road, Chrompet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9884157975 |
| Fax |
|
| Email |
ajaykumar.anandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharanya |
| Designation |
Junior Resident |
| Affiliation |
Sree Balaji Medical College |
| Address |
Department of Anesthesia, pain Clinic and Critical Care, Sree Balaji Medical College, No 7, CLC Works road, Chrompet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
7550249469 |
| Fax |
|
| Email |
sharanya.sharanya.p@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College, No7, CLC Works road, Chrompet, Chennai-600044 |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College |
| Address |
Sree Balaji Medical College, No 7, CLC Works road, Chrompet, Chennai-600044 |
| 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 Sharanya |
Sree Balaji Medical College |
III Floor , ORC, Department of Anesthesia Pain clinic and Critical Care, Sree Balaji Medical College, Chrompet, Chennai-600044
Chennai
TAMIL NADU |
7550249469
sharanya.sharanya.p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infraclavicular Approach to Brachial plexus Block |
Under Ultrasound Guidance Brachial plexus Will be Blocked Using Infraclavicular Approach with 0.5% of 30ml of bupivacaine |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Supraclavicular Approach to brachial plexus Block |
Under Ultrasound Guidance, the Brachial plexus Will be Blocked Using Supraclavicular Approach with 0.5% of 30 ml of bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II patients undergoing elective upper limb procedures |
|
| ExclusionCriteria |
| Details |
- ASA III and above
- coagulation disorders
- significant pulmonary pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory Blockade of the Upper Limb |
After Administration of Block Postoperatively 20mins 40 mins 1 hr every 1hr till 6hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative Analgesics Consumption |
After Administration of Block Postoperatively 20mins 40 mins 1 hr every 1hr till 6hrs upto 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/09/2018 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Brachial plexus block remain the only practical alternative to general anaesthesia for significant surgery on the upper limb. Peripheral nerve stimulation is now being largely superseded by ultrasound – guidance because of the increasing number of advantages. routine assessment done and 40 asa 1&2 patients selected and will be grouped by computer generated randomisation into supraclavicular and infra clavicular group. both the blocks will be performed under ultrasound guidance with 30ml of 0.5%bupivacaine and time of sensory and motor blockade and requirement of first post op analgesia will be assessed. |