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CTRI Number  CTRI/2024/06/069242 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain relief injections by using ultrasound machine to nerve groups in neck for thyroid removal surgeries for continuous pain relief even after surgery. 
Scientific Title of Study   A Randomized Comparative Double Blinded Study of Postoperative Analgesic efficacy of 0.25 percent ropivacaine with Dexmedetomidine versus 0.25 percent ropivacaine with dexamethasone in ultrasound guided bilateral superficial cervical plexus block for thyroidectomy patients 
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 Kavselyaa Rai V 
Designation  Post Graduate student in Department of Anesthesiology Vijayanagar institute of medical sciences  
Affiliation  Vijayanagar Institute of medical sciences, Rajiv Gandhi University of medical sciences  
Address  Post Graduate Department of Anaesthesiology Vijayanagar institute of medical sciences

Bellary
KARNATAKA
583104
India 
Phone  9790120371  
Fax    
Email  vkavsirai1800@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavselyaa Rai V 
Designation  Post Graduate in Department of Anesthesiology  
Affiliation  Vijayanagar institute of medical sciences, Rajiv Gandhi University of medical sciences  
Address  Post Graduate Department of Anesthesiology Vijayanagar institute of medical sciences, Cantonment, Ballari

Bellary
KARNATAKA
583104
India 
Phone  9790120371  
Fax    
Email  vkavsirai1800@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raghunath S S 
Designation  Associate Professor in Department of Anesthesiology  
Affiliation  Vijayanagar institute of medical sciences, Rajiv Gandhi University of medical sciences  
Address  Department of Anesthesiology, Vijayanagar institute of medical sciences

Bellary
KARNATAKA
583104
India 
Phone  9945434495  
Fax    
Email  docraghu2009@gmail.com  
 
Source of Monetary or Material Support  
Vijayanagar institute of medical sciences, Ballari 583104 Karnataka India 
 
Primary Sponsor  
Name  Vijayanagar institute of medical sciences  
Address  Department of Anesthesiology Cantonment Ballari Karnataka 583104 Karnataka India  
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 Kavselyaa Rai V  Vijayanagar institute of medical sciences   Department of Anesthesiology, Major OT Complex, Cantonment
Bellary
KARNATAKA 
9790120371

vkavsirai1800@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Vijayanagar Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone   0.25% ropivacaine added with dexamethasone 0.05mg/kg diluted to 1 ml and under Ultrasound guidance, superficial cervical plexus is identified and given and post operative analgesic is observed at baseline followed by every 30 minutes till 24 hours 
Intervention  Dexmedetomidine   0.25% ropivacaine added with dexmedetomidine 1mcg/kg under Ultrasound guidance, superficial cervical plexus is identified and given and post operative analgesic is observed at baseline followed by every 30 minutes till 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Normal cardiopulmonary status
Patients with euthyroid status
ASA I , II 
 
ExclusionCriteria 
Details  Refusing to be a part of study
Allergy of Drug
Neural disorder
Substernal goitre
Bleeding, Hypertension, Diabetes
Recent steroid or opioid usage
Stridor
Infection at local site

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia with 0.25% ropivacaine with dexmedetomidine and dexamethasone   0 time at 9.00am every 30 minutes for 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Rescue Analgesic Requirement in the first 24 post operative hours
Measure postoerative pain assessment by NRS scoring 
0 time at 9.00Am every 30 minutes for 24 hours 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   30/06/2024 
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  
Thyroidectomy is associated with moderate incisional pain, burning sensation, uneasiness in swallowing and post-operative nausea vomiting (PONV) attributable to endotracheal intubation, tissue dissection, and hyperextension during surgery. 
            Cervical plexus blocks can be performed in patients undergoing thyroid surgery and prolonged postoperative analgesia can be provided by administering local anaesthetic solutions with or without adjuvant. It has been reported that up to 90% of patients require narcotic analgesics during the first postoperative day.
             BSCPB is a procedure with a low serious complication rate. The risks of phrenic nerve palsy and total spinal anaesthesia from injection into a dural cuff are restricted to blockade of the deep cervical plexus only; diffusion of local anaesthetic is not sufficient to account for these phenomena with a superficial technique
                Local anaesthetics, when used alone, offer a short duration of analgesia. Therefore, various adjuvants have been studied, including dexmedetomidine, an α2 agonist, which provides stable haemodynamics, and prolonged analgesia with minimal side effects and Dexamethasone, a corticosteroid, is a recent addition to the list with promising results in BSCPB.
            We will be investigating the effects of dexmedetomidine and dexamethasone as adjuvants with ropivacaine on the duration of analgesia as a primary outcome and NRS, rescue analgesic requirement, haemodynamic parameters, PONV, and adverse events as secondary outcomes in BSCPB for thyroidectomy under general anaesthesia

Patients of ASA I and II of either sex posted for elective thyroidectomy under general anesthesia, will be randomly assigned to each group (A and B). After obtaining written informed consent, participants will be randomized to receive bilateral SCPB with Group A will be receiving ropivacaine 0.25% with dexmedetomidine 1mcg/kg and Group B will be receiving ropivacaine 0.25% with dexamethasone 0.05mg/kg 1ml.
               To reduce subjective and objective bias, the study will be double-blinded so that the anaesthesiologist doing the procedure, the patient, and the monitoring personnel will be not aware of group allocation i.e., the mixture used for the BSCPB. The syringe will be labelled with a number, and a record of the syringe’s contents will be preserved.
          Patients in this trial will be evaluated by taking detailed history, airway assessment, and routine investigations along with thyroid function tests. All standard ASA monitors connected and baseline vitals will be recorded. Patients will be given intravenous midazolam 0.02 mg/kg and fentanyl 2µg/kg as premedication along with preoxygenation with 100% oxygen. Propofol 2 mg/kg and vecuronium 0.1 mg/kg will be used for inducing general anaesthesia, which will be followed by tracheal intubation. Anaesthesia will be maintained with inhalational agent sevoflurane (MAC 0.7–1.3) in a mixture of O2 :N2 O in a ratio of 50:50. 
                             The block is normally performed in supine position with the patients head turned to the contra-lateral side. Once the skin is cleaned and prepared with antiseptic, the transducer is placed over the lateral side of the neck at the midpoint of the posterior border of the sternocleidomastoid muscle (SCM).The patients will undergo ultrasound evaluation with SONOSITE (linear probe- 5-12 MHz). The transducer is positioned such that the tapering end (posterior border on the ultrasound image) of the SCM is in the centre of the screen . The needle is then introduced from the posterior aspect through the skin and platysma and 5-10 ml of LA deposited just behind this landmark. This will involve two injections, starting from mid-point of SCM, one from caudal to cranial end and the second one from cranial to caudal end.
Duration of Postoperative analgesia: The time between the onset of block and the first rescue analgesia i.e., NRS more than or equal to 4.
Rescue Analgesia: Injection Tramadol 1mg/kg.
Side effects- PONV, Shivering will be assessed.
Sedation score is assessed by Modified Ramsay Sedation score
 
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