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CTRI Number  CTRI/2025/11/096827 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of anaesthesia techniques in patients posted for thyroid surgeries  
Scientific Title of Study   Randomised controlled trial comparing ultrasound guided cervical plexus block with general anaesthesia for elective Hemi-Thyroidectomy surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Narender Bhandari 
Designation  Assistant Professor  
Affiliation  RIMS ADILABAD  
Address  Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad, Rickshaw colony, Adilabad, Telangana, 504001

Adilabad
TELANGANA
504001
India 
Phone  9701853153  
Fax    
Email  narenderbhandari77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Belli Yashaswi 
Designation  Assistant Professor  
Affiliation  RIMS ADILABAD  
Address  Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad, Rickshaw colony, Adilabad, Telangana, 504001

Adilabad
TELANGANA
504001
India 
Phone  7382945043  
Fax    
Email  yashaswini.belli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Belli Yashaswi 
Designation  Assistant Professor  
Affiliation  RIMS ADILABAD  
Address  Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad,Rickshaw colony, Adilabad, Telangana, 504001

Adilabad
TELANGANA
504001
India 
Phone  7382945043  
Fax    
Email  yashaswini.belli@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  RIMS ADILABAD  
Address  Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad,Rickshaw colony, Adilabad, Telangana, 504001 
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 Yashaswi  RIMS ADILABAD   Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad,Rickshaw colony, Adilabad, Telangana, 504001
Adilabad
TELANGANA 
7382945043

yashaswini.belli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee RIMS Adilabad   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  Cervical plexus block  Bilateral superficial plexus ipsilateral deep cervical plexus block 
Comparator Agent  General anaesthesia   Propofol, vecuronium, nalbuphine, midazolam 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients
Elective surgeries fit for general anaesthesia
 
 
ExclusionCriteria 
Details  Patient with IHD,CAD,COPD,ILD, ASTHMA
Obese patients
Difficult airway and intubation
Children and pregnant patients
Fearful and uncooperative patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Adequacy of block, duration of analgesia   30 min after surgery, 2 hours, 6 hrs and 24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative analgesia  6 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   21/11/2025 
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="0"
Months="6"
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  
AIM and OBJECTIVES
The aim of this study is to compare the Ultrasound guided cervical plexus block with general anesthesia for elective Hemi-thyroidectomy surgeries in terms of:
 Intraoperative hemodynamic stability ,Patient satisfaction
Post operative analgesia requirement , PONV and antiemitic requirement
Time of postoperative revival
Duration of recovery stay
INTRODUCTION
Thyroid surgery is one of the frequently performed surgical procedures.1 Both general anesthesia (GA) and cervical plexus anesthesia (CPA) can be used for thyroidectomy surgeries. The use of regional anaesthesia in thyroid surgery remains controversial. Cervical Plexus Blocks(CPB) are regional anesthesia techniques that can be used alone or in combination with GA for various head and neck surgeries.
CPB alone can provide effective anaestesia in pain relief for procedure involving the anterior-lateral neck, upper shoulder and posterior scalp. In our study, we are comparing CPB with GA for anterior-lateral neck surgery hemi-thyroidectomy. Unilateral deep cervical plexus block and bilateral superficial block are given for hemi-thyroidectomy surgeries.
Ultrasound guided technique has the advantages over the landmark based technique include the ability to visualise the spread of local anesthetic in correct plane, which therefore increases the success rate. It also avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures. Regional blocks in thyroid surgeries has the advantage to monitor voice and breathing during surgery.
 
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