| CTRI Number |
CTRI/2025/07/092074 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different doses of a ropivacaine used for nerve block in forearm and hand surgeries using ultrasound guidance |
|
Scientific Title of Study
|
Comparison of the efficacy of 0.375percentage versus 0.5percentage of ropivacaine for ultrasound guided brachial plexus block through costoclavicular space approach in patients undergoing forearm and hand surgeries a randomised double blind non inferiority clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirana G K |
| Designation |
Post graduate Student |
| Affiliation |
Karnataka Medical College and Research Institute Hubballi |
| Address |
206 Department of anesthesia KMCRI Hospital KIMS Campus Vidyanagar Hubballi 580021 KMCRI KIMS Campus Vidyanagar Hubballi 580021 Dharwad KARNATAKA 580021 India |
| Phone |
9916901710 |
| Fax |
|
| Email |
kiranagk07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Basavaraj Kallapur |
| Designation |
Professor |
| Affiliation |
Karnataka Medical College and Research Institute Hubballi |
| Address |
206, Department of anesthesia KMCRI KIMS Campus Vidyanagar Hubballi 580021 206 Department of anesthesia KMCRI
KIMS Campus Vidyanagar Hubballi 580021 Dharwad KARNATAKA 580021 India |
| Phone |
6364503729 |
| Fax |
|
| Email |
doc_basu@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Kirana G K |
| Designation |
Post graduate student |
| Affiliation |
Karnataka Medical College and Research Institute Hubballi |
| Address |
206 Department of anesthesia KMCRI KIMS Campus Vidyanagar Hubballi 580021 206 Department of anesthesia KMCRI
KIMS Campus Vidyanagar Hubballi 580021 Dharwad KARNATAKA 580021 India |
| Phone |
9916901710 |
| Fax |
|
| Email |
kiranagk07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Medical College and Research Institute,KIMS Campus Vidyanagar Hubballi Dharwad district,Karnataka,India 580021 |
|
|
Primary Sponsor
|
| Name |
Karnataka Medical College and Research Institute |
| Address |
KMCRI ,KIMS Campus Vidyanagar Hubballi,Dharwad district, Karnataka ,India 580021 |
| 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 KIRANA G K |
Karnataka Medical College and Research Institute |
206, Department of anesthesia KMCRI,KIMS Campus, Vidyanagar Hubballi, Dharwad district,Karnataka,India 580021 Dharwad KARNATAKA |
9916901710
kiranagk07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.375percent of ropivacaine |
20ml of 0.375percent of ropivacaine is administered through the costoclavicular space approach under ultrasound guidance for the orthopedic patients undergoing forearm and hand surgeries. We observe for the onset of sensory and motor blockade every five minutes for 30minutes. Later we observe for duration of action of the block after the surgery every hour till the return of sensory and motor blockade. We also assess the pain score postoperatively |
| Comparator Agent |
0.5percent of ropivacaine |
20ml of 0.5percent of ropivacaine is administered through the costoclavicular space approach under ultrasound guidance for the orthopedic patients undergoing forearm and hand surgeries. We observe for the onset of sensory and motor blockade every five minutes for 30minutes. Later we observe for duration of action of the block after the surgery every hour till the return of sensory and motor blockade. We also assess the pain score postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with upper limb bone fracture
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patients with sensory or motor defecits
2. Allergic to local anaesthetics
3. Prior surgery in the infra clavicular fossa
4. Bleeding tendencies and coagulopathies
5. Infection at the site of injection
6. History of cerebrovascular accidents
7. Patients with emphysema or COPD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory and motor blockade |
Every five minutes upto thirty minutes from the injection of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for reversal of sensory & motor blockade & appearance of pain |
Every one hour till the patient is able to gain the sensations & motor power |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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 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
|
The costoclavicular brachial plexus block (CCB) is a recently introduced infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space . Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered, while maintaining a consistent anatomical relationship with each other
Brachial plexus blockade (BPB) thorough the costoclavicular space block is widely used anaesthesia technique nowadays in the upper limb surgery . Previously peripheral never block was given with Perineural injections guided by surface anatomy or electrical nerve stimulation but recently the ultrasound guided are more successful than injections guided by surface anatomy or electrical neurostimulation.The classical approaches to BPB include interscalene, supraclavicular, infraclavicular, and axillary approaches.
Recently, with the advances in technology ultrasonography guidance has got more attention and has been used to give the BPB through the costoclavicular space (CCS) and considered as an alternative access pathway to BPB. The CCS is located between the clavicle and the first rib, deep behind the middle of the clavicle.The CCS was introduced as a feasible pathway for BPB by Dahlstrom and Olinger in 2012 in their study of thoracic outlet syndrome,which was later confirmed in a 2016 autopsy study by Sala–Blanch et al.Subsequent studies using the ultrasound-guided CCS approach to BPB, found that the compact anatomy of the CCS had little interindividual variability and allowed for simple performance with few complications and a high success rate, all of which increases the feasibility for continuous nerve blockade through this approach.In recent years, few studies have applied this approach to special groups of individuals, such as pediatric and obese patients, and reported satisfactory results.
In most of these studies, 0.5% ropivacaine was used but the recent research has shown effective ultrasound-guided supraclavicular BPB using lower local anesthetic concentrationsof ropivacaine and the data obtained from few articles provided an information that 0.375% ropivacaine may be effective when given in the CCS. As the risk of systemic (LAST) and direct neurotoxicity increases with higher concentrationsof the drug chances of inadvertentvascukar and pleural injuries may be associated with the block, so we felt it is very important to understand if a lower concentration of ropivacaine can be used for BPB in the CCS under the ultrasound guidance. Hence, the purpose of this study is to compare the efficacy of 0.375% ropivacaine with 0.5% ropivacaine in ultrasound-guided BPB through the CCS. Our hypothesis is that 0.375% ropivacaine would be noninferior to 0.5% ropivacaine in producing successful BPB when given in the CCS under the ultrasound guidance.
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