| CTRI Number |
CTRI/2022/11/047078 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two different approaches for infraclavicular block |
|
Scientific Title of Study
|
“A comparative evaluation of ultrasoundguided costoclavicular and paracoracoid approach to infra clavicular blocks for upper limb surgeries.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NATESH S RAO |
| Designation |
PROFESSOR |
| Affiliation |
Vydehi institute of medical science and research centre |
| Address |
Vydehi institute of medical science and research centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Vydehi institute of medical science and research centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
8861610735 |
| Fax |
|
| Email |
anaesth_natesh2951@vimsmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NATESH S RAO |
| Designation |
PROFESSOR |
| Affiliation |
Vydehi institute of medical science and research centre |
| Address |
Vydehi institute of medical science and research centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Vydehi institute of medical science and research centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
8861610735 |
| Fax |
|
| Email |
anaesth_natesh2951@vimsmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NATESH S RAO |
| Designation |
PROFESSOR |
| Affiliation |
Vydehi institute of medical science and research centre |
| Address |
Vydehi institute of medical science and research centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Vydehi institute of medical science and research centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
8861610735 |
| Fax |
|
| Email |
anaesth_natesh2951@vimsmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi institute of medical sciences #82 EPIP AREA, WHITEFIELD BANGLORE - 560066
|
|
|
Primary Sponsor
|
| Name |
Vydehi institute of medical science |
| Address |
Vydehi institute of medical science and research centre |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meghana M |
Vydehi institute of medical sciences and research |
Department of Anesthesiology Vydehi hospital
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA |
08892030050
meghanachoudary911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institutional Ethics Committee |
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 |
Infraclavicular block for fore arm surgeries costoclavicular approach |
25ml 0.5% Levobupivacaine plus 2mg Dexamethasone |
| Comparator Agent |
Infraclavicular block for fore arm surgeries through paracoracoid approach |
25ml 0.5% Levobupivacaine plus 2mg Dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA I-II.
BMI < 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
a) Patients with coagulopathy.
b) Patients with sepsis.
c) Patients with pre-existing neuropathy involving brachial plexus. d) Patients who have undergone prior surgeries of the infraclavicular fossa. e) Patients with localized skin infections of the infraclavicular fossa.
f) Patients with allergy to Local Anesthetics. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study and compare,
a) Time to complete Sensory and Motor Block
b) Duration of post-operative analgesia |
0, 6hr, 12hr ,24hr , 48hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemo-dynamic changes in the intra-operative period b) Adverse effects of costoclavicular or Paracoracoid approach to IBPB |
0, 6hr, 12hr, 24hr, 48hr |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
10/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/11/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Infraclavicular brachial plexus block through paracoracoid approach, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to axillary artery. All 3 cords of brachial plexus are separated from one another in this approach and may not be seen in single ultrasound window. Whereas in costoclavicular approach, the cords in the costoclavicular space are relatively superficial, clustered together and arranged in a triangular shape. In costoclavicular space all the 3 cords of brachial plexus can be identified in single transverse sonogram making it better suited for the successful use of ultrasound to perform brachial plexus block. This study is conducted to compare, the block onset time, block related pain scores |