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CTRI Number  CTRI/2025/03/081905 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 08/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   THE STUDY COMPARES THE EFFECTS OF ISOBARIC LEVOBUPIVACAINE 0.25 percent AGAINST ISOBARIC ROPIVACAINE 0.25 percent IN ULTRASOUND GUIDED BILATERAL SUPERFICIAL CERVICAL PLEXUS BLOCK FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING THYROID OPERATIONS UNDER GENERAL ANAESTHESIA 
Scientific Title of Study   A Comparative study to evaluate the effect of ultrasound guided bilateral superficial cervical plexus block for postoperative analgesia using isobaric bupivacaine 0.25 percent versus isobaric ropivacaine 0.25 percent in patients undergoing thyroid surgeries under general anaesthesia 
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 Soundarya T N  
Designation  Post Graduate student  
Affiliation  Chamarajanagara Medical college 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India
CIMS ROAD
Chamarajanagar
KARNATAKA
571313
India 
Phone  7892979114  
Fax    
Email  soundaryatn98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Darshan M S 
Designation  Head of Department  
Affiliation  Chamarajanagara Medical college 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India

Chamarajanagar
KARNATAKA
571313
India 
Phone  9741376797  
Fax    
Email  darshanms_jss@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Soundarya T N 
Designation  Post Graduate student  
Affiliation  Chamarajanagara Medical college 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Yadapura , CHAMARAJANAGAR Chamarajanagar KARNATAKA 571313 India Chamarajanagar KARNATAKA 571313 India

Chamarajanagar
KARNATAKA
571313
India 
Phone  7892979114  
Fax    
Email  soundarayatn98@gmail.com  
 
Source of Monetary or Material Support  
Chamarajanagara institute of medical sciences Kasaba hobli, yadapura, Karnataka -571313  
 
Primary Sponsor  
Name  Chamarajanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Kasaba hobli, Yadapura, Karnataka -571313 
Type of Sponsor  Government medical college 
 
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 DARSHAN MS   Chamarajanagar Institute of Medical Sciences Chamarajanaga  Department of Anaesthesiology Chamarajanagar Institute of Medical Sciences Chamarajanagar Chamarajanagar KARNATAKA
Chamarajanagar
KARNATAKA 		 9741376797

darshanms_jss@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Iinstitutional Ethics committee   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  Inj levobupivacaine 0.25%   inj levobupivacaine 0.25% 5ml with 5ml NS given for superficial cervical plexus block given bilaterally 
Comparator Agent  Inj ropivacaine 0.25%   Inj ropivacaine 0.25% 5ml with 5ml of NS for superficial cervical plexus block given bilaterally  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA Class I and II patients posted for elective thyroidectomy under general anesthesia.
2. Age group between 18-60 years of both the gender who are willing to participate and has given informed consent.
 
 
ExclusionCriteria 
Details  Know to have allergy to any of study drugs
Any local infection
Any history of pulmonary, cardiac, renal, endocrine disorders
Previous cervical surgery
Pre-existing peripheral nerve neuropathies
Patients with history of coagulation disorders or any history of anticoagulant intake

 
 
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 
To study the duration of postoperative analgesia after superficial cervical plexus block   Till the first complain of postoperative pain 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate requirement of analgesics in post operative period.
To assess and compare the perioperative hemodynamic characteristics between the two drugs
To assess complications and or side effect among drugs 		 Post op day 0 and 1 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   18/03/2025 
Date of Study Completion (India) 31/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [soundaryatn98@gmail.com].

  6. For how long will this data be available start date provided 02-03-2025 and end date provided 02-03-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  
Most of the patients undergoing thyroidectomy surgeries under general anaesthesia, but postoperative analgesia has been challenging. Acute postoperative pain is commonest complaint.  Since superficial cervical plexus block is proposed for analgesia effect and reduces requirement of opioids and hasten the recovery and reduces the hospital stay. The present study is being done to assess efficacy and hemodynamics of inj levobupivacaine 0.25% and ropivacaine 0.25% in superficial cervical plexus block.

 
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