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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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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