| CTRI Number |
CTRI/2025/07/090314 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of two drugs the control 0.5 percent levobupivacaine and the test 0.75 percent ropivacaine used in ultrasound guided below clavicle nerve block in patients posted for lower arm and forearm surgeries |
|
Scientific Title of Study
|
Comparison of the efficacy of 0.5 percent levobupivacaine versus 0.75 percent ropivacaine in ultrasound guided costoclavicular block for upper limb surgeries - A prospective randomized control 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 Diksha Dmello |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anesthesiology
Kasturba Hospitals Manipal
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9591463444 |
| Fax |
|
| Email |
dikshadmello27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diksha Dmello |
| Designation |
Senior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anesthesiology
Kasturba Hospitals Manipal
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9591463444 |
| Fax |
|
| Email |
dikshadmello27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Dmello |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Anesthesiology
Kasturba Hospitals Manipal
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9591463444 |
| Fax |
|
| Email |
dikshadmello27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospitals
Manipal
Udupi
Karnataka - 576104
India |
|
|
Primary Sponsor
|
| Name |
Dr Diksha Dmello |
| Address |
Department of Anesthesiology
Kasturba Hospitals, Manipal
Karnataka 576104
India
|
| Type of Sponsor |
Other [self] |
|
|
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 Diksha M Dmello |
Kasturba Hospitals |
Department of Anesthesiology
Manipal - 576104
Udupi
KARNATAKA |
9591463444
dikshadmello27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical College and Kasturba hospitals, 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 |
Drug intervention |
Group L- a single injection of 20ml of 0.5% levobupivacine under ultrasound guidance given as a peripheral nerve block with a duration of action up to 6 to 8 hours |
| Comparator Agent |
Drug intervention |
Group R - Single injection 20 ml of 0.75% ropivacaine under ultrasound guidance given as a peripheral nerve block with duration of action of 6 to 8 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 65 years
ASA physical status 1 and 2 and 3
Voluntary participation in the trial
Surgeries for upper limb below mid shaft of humerus under brachial plexus block
|
|
| ExclusionCriteria |
| Details |
Refusal to participate
Local anesthetic allergy
Infection at block site
Prior infraclavicular fossa surgery
Bleeding or evidence of coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the mean duration of sensory block between the two groups
|
2, 4, 6, 8, 10 , 12 hours post operatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset of sensory block |
0, 5, 10, 15, 20, 25 and 30 mins after injection |
| onset of motor block |
0, 5, 10, 15, 20, 25 and 30 minutes after injection |
| Duration of motor block |
from time of injection to 2, 4, 6, 8, 10 and 12 hours post operatively or upto motor block receeding. |
| time to first analgesic requirement |
to be assessed at 2,4,6,8,10 & 12 hours post operatively for pain |
| Incidence of block failure |
assessed at 0, 5, 10, 15, 20, 25 up to 30 mins after injection |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Costoclavicular approach is a modification of the infraclavicular brachial plexus block, It’s a novel and upcoming ultrasound technique with known reliable analgesia, compact anatomy and higher patient safety. Ropivacaine and levobupivacaine are being widely used due to their long duration of action and higher safety profile. Their action in the costoclavicular approach has not been studied yet. We hypothesize that they will have equal mean duration of analgesic action but ropivacaine with a higher sensory propensity will show early motor regression and is more advantageous for early post operative rehabilitation. |