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CTRI Number  CTRI/2025/02/081142 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   COMPARISION OF ONSET TIME OF TWO CONCENTRATIONS OF ROPIVACAINE IN THE POPULATION OF ASSAM 
Scientific Title of Study   COMPARISION OF ONSET TIME OF SENSORY BLOCK WITH 0.5% and 0.375% ROPIVACAINE IN USG GUIDED INFRACLAVICULAR BRACHIAL PLEXUS BLOCK  
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 Saurav Kalita  
Designation  Post Graduate Trainee  
Affiliation  Gauhati Medical College and Hospital  
Address  Department of Anesthesiology and Critical care, Gauhati Medical College and Hospital Bhangagarh

Kamrup
ASSAM
781032
India 
Phone  8486561403  
Fax    
Email  sauravkalitamjj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyam Saikia 
Designation  Associate Professor  
Affiliation  Gauhati Medical College and Hospital  
Address  Department of Anesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh

Kamrup
ASSAM
781032
India 
Phone  9706067392  
Fax    
Email  saikia.priyam80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyam Saikia  
Designation  Associate Professor  
Affiliation  Gauhati Medical College and Hospital  
Address  Department of Anesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh

Kamrup
ASSAM
781032
India 
Phone  9706067392  
Fax    
Email  saikia.priyam80@gmail.com  
 
Source of Monetary or Material Support  
Gauhati Medical College and Hospital post office Bhangagarh police station Bhangagarh District Kamrup Metro State Assam PIN 781032 
 
Primary Sponsor  
Name  Dr Saurav Kalita  
Address  Department of Anesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh District Kamrup Metro State Assam PIN 781032  
Type of Sponsor  Other [Self] 
 
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 Saurav Kalita   Gauhati Medical College and Hospital   Department of Anesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh
Kamrup
ASSAM 		 8486561403

sauravkalitamjj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee,Gauhati Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Injection Ropivacaine   0.5% and 0.375 % Ropivacaine is administered via usg guided infraclavicular brachial plexus block and the onset of sensory block is noted in both groups 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients age group 18 to 65 years ,of all sexes
2, ASA grade 1 and 2
3.patient with elective orthopedic surgery for arm,elbow,forearm and hand under US –guided infraclavicular approach
4.Patient who are willing to give informed and written consent for the surgery.
 
 
ExclusionCriteria 
Details  1.Patient refusal for infraclavicular brachial plexus block
2.Patient with brachial plexus neuropathies,diabetes ,any known peripheral neuropathic disease,post CVA
3.severe brochopulmonary disease
4.coagulopathies
5. severe cardiac diseases
6.pregnancy
7.intolerance or known history of allergy to one or more medications of the study
8.Patient undergoing emergency surgeries
9 local infection at the site of the block

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time of onset of sensory block between 0.5% and 0.375 % ropivacaine
 		 To compare the time of onset of sensory block between 0.5% and 0.375 % ropivacaine in orthopedic patients within 30 minutes of performing the block prior to Surgery at baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the onset time of motor block
2.Intraoperative hemodynamics ,
3.The requirements of supplemental anesthesia or analgesic
4.Occurrence of any complications
 		 To compare the onset time of motor block,Intraoperative hemodynamics ,
The requirements of supplemental anesthesia or analgesic
and Occurrence of any complications in orthopedic patients within 30 minutes of performing the block prior to surgery at baseline
 
 
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   Phase 4 
Date of First Enrollment (India)   18/03/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sauravkalitamjj@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Infraclavicular brachial plexus block provides sufficient anesthetic and analgesic effect for lower arm surgery (3).Infraclavicular approach also has a short procedure time compared to other approaches including supraclavicular and axilliary approaches ( Therefore ultrasound- guided infraclavicular brachial plexus block has been increasingly used .  At centres with high volume of patient load ,onset time is one of the most important considerations for choosing a local local anaesthetic drug.To hasten the time of onset of the block ,higher concentration of local anaesthetics are used (8) .However higher concentration of local anesthetics causes direct neurotoxicity to the neurons .The volume and concentration of the drug must be carefully selected to avoid exceeding the maximal dose. (9)Thus, the use of diluted local anesthetics may be safer .Therefore we aimed to compare the onset times of 0.5% and0.375% ropivacaine for infraclavicular brachial plexus block

 
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