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CTRI Number  CTRI/2025/05/086460 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   We will study the effect of superficial cervical plexus block on pain relief after surgery of thyroid gland under general anaesthesia. 
Scientific Title of Study   Effect of bilateral superficial cervical plexus block on postoperative analgesia in thyroid surgery under general anaesthesia Randomized controlled 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  Dr Neetu kumari 
Designation  Post graduation resident 
Affiliation  Rajendra Institute of Medical Science Ranchi Jharkhand India 834009 
Address  Department of Anaesthesiology RIMS Ranchi Bariatu Jharkhand India 834009

Ranchi
JHARKHAND
834009
India 
Phone  7991131384  
Fax    
Email  pmchneetu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Azizul Haque 
Designation  Associate Professor  
Affiliation  Rajendra Institute of Medical Science Ranchi Jharkhand India 834009 
Address  Department of Anaesthesiology RIMS Ranchi Jharkhand India 834009

Ranchi
JHARKHAND
834009
India 
Phone  8092759512  
Fax    
Email  drazizulhaque61@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Shrivastava  
Designation  Assistant Professor  
Affiliation  Rajendra Institute of Medical Sciences, Ranchi , Jharkhand , India 834009 
Address  Department of Anesthesiology RIMS Ranchi, Jharkhand, India 834009

Ranchi
JHARKHAND
834009
India 
Phone  9958912712  
Fax    
Email  shrivastava2911@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India, 834009 
 
Primary Sponsor  
Name  Dr Neetu Kumari 
Address  Department of Anaesthesiology RIMS, Ranchi, Jharkhand, India, 834009 
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 Neetu Kumari  Rajendra Institute of Medical Sciences  Room no 1, Department of Anaesthesiology
Ranchi
JHARKHAND 		 7991131384

pmchneetu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi, Jharkhand 834009  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E071||Dyshormogenetic goiter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral superficial cervical plexus block  In cases of thyroid surgery under general anaesthesia we will block bilateral superficial cervical plexus, and will observe for pain in post operation time.  
Comparator Agent  No block   In this group of patients no block is given but patients are observed for pain in post operative time.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status I and II
Weight more than 30Kgs
Age 18 to 65 years
Patients with informed and written consent
 
 
ExclusionCriteria 
Details  Any local infection at the site of giving the block
Known allergy to local anaesthetic agent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the time of requirement of rescue analgesia in post operative period  Till 24 hour after end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the vital parameters NIBP SPO2 HR intraoperatively & postoperatively till the requirement of rescue analgesia
 
To evaluate PONV & pain using verbal analogue scale in two groups till the requirement of rescue analgesia
 		 Intraop vitals at 5 10 15 20 25 30 35 40 45 50 minutes interval till the end of surgery

VAS score every 2 hour for first 8 hour then after 4 hourly till 24 hour 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/05/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Patients undergoing thyroid surgery will be randomly allocated in two groups are Group R and Group C.
GROUP R.25% 10 ml ropivacaine + .25mcg/kg dexmedetomidine on each side plus general anaesthesia
GROUP C only general  anaesthesia .
 Written and informed consent from the patient will be taken.
 Pre anaesthetic check-up will be done a day before surgery including detailed history, thorough physical examination and systemic examination. Age ,sex, body weight and ASA grading will be recorded.
 Routine investigation- CBC, Thyroid profile , random blood sugar, serum urea, serum creatinine, coagulation profile will be checked on day of surgery.
 Patient will be taken in operation theatre and all essential monitor will be attached such as ECG, NIBP, SPO2.
 Two iv access of 18 G in both the hands will be obtained.
 The patient will be premedicated with inj. Midazolam 0.02mg/kg followed by inj. fentanyl 2mcg/kg, preoxygenated for 3 minutes with 100% oxygen.
 Induction will be done with inj. propofol (1.5mg/kg) and inj. Vecuronium .1mg/kg will be given for muscle paralysis and then after bag and mask ventilation of 3 minutes
patients trachea will be intubated with appropriate size of endotracheal tube.
 Maintenance will be done by oxygen, nitrous oxide and sevoflurane with 1 MAC along with maintenance dose of Vecuronium.
 Inhalational agent sevoflurane will be titrated during the course of surgery.
 Subjects who will be randomized to
Group R will receive USG guided BSCPB with 10ml 0.25% Ropivacaine +. 25mcg/kg dexmedetomidine on both sides .
Group C will not receive any block
 In order to ensure double blinding the doctor who will give the block and the doctor who
will record the parameter will be different and the doctor who record the parameter will not be present in operation theatre at the time of giving the block.
USG GUIDED:
 Ultrasound guided BSCPB will be performed by using  sonosite  model of USG machine with 4 cm linear.
 transducer with a frequency of 5-10 MHZ.
 Then 20G needle will be attached toa 10cm iv extensor line for injecting the drug.
 This nerve block will be performed in supine or semi- sitting position ,with head turned
slightly away from the side to be blocked to facilitate operator access
 With the patient in proper position , the skin will be disinfected and transducer is placed on lateral neck, overlying SCM at the level of its midpoint.
 The cervical plexus will be visible as a small collection of hypoechoic nodules (honeycomb appearance)immediately superficial to prevertebral fascia
 Once the plexus has been identified, the needle will be passes through skin ,platysma and the investing layer of deep cervical fascia and the tip will be placed adjacent to plexus after negative aspiration of blood to exclude vascular puncture, drug will be injected.
 We will observe heart rate and systolic blood pressure (SBP), diastolic blood pressure (DBP) mean arterial pressure (MAP) and End tidal carbon dioxide (ETCo2) during the
surgery at 5, 10, 15, 20, 25 ,30 ,35,40,45 at 50 minutes interval till the end of surgery.
 Patients of all the groups will be observed every 2 hour for first 8 hour then after every 4 hourly till 24 hours of surgery for pain assessment. Visual Analogue Scale (VAS) will be used to access pain.
 
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