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CTRI Number  CTRI/2024/02/062922 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On: 13/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of bilateral superficial cervical plexus block versus local wound infiltration using a bupivacaine dexamethasone mixture 
Scientific Title of Study   Comparative Study of Analgesic Efficacy of Preoperative Bilateral Superficial Cervical Plexus Block with that of Simple Wound Infiltration with Bupivacaine Dexamethasone Mixture for Thyroidectomies - A Prospective Blinded Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwini H 
Designation  Professor 
Affiliation  Rajarajeshwari Medical College and Hospital 
Address  Department of Anaesthesia, Rajarajeshwari Medical College and Hospital, Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  ashwinih@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashwini H 
Designation  Professor 
Affiliation  Rajarajeshwari Medical College and Hospital 
Address  Department of Anaesthesia, Rajarajeshwari Medical College and Hospital, Bengaluru


KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  ashwinih@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ashwini H 
Designation  Professor 
Affiliation  Rajarajeshwari Medical College and Hospital 
Address  Department of Anaesthesia, Rajarajeshwari Medical College and Hospital, Bengaluru


KARNATAKA
560074
India 
Phone  8971265579  
Fax    
Email  ashwinih@yahoo.com  
 
Source of Monetary or Material Support  
Rajarajeshwari Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Aditya Kheny 
Address  Department of Anaesthesia, Rajarajeshwari Medical College and Hospital 
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 Aditya Kheny  Rajarajeshwari Medical College and Hospital  Department of Anaesthesia, Rajarajshwari Medical College and Hospital
Bangalore
KARNATAKA 
9483149909

khenyaditya97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E012||Iodine-deficiency related (endemic) goiter, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral Superficial Cervical Plexus Block  Patients undergoing thyroidectomies will be into group A. Group A will receive Bilateral Superficial Cervical Plexus Block with 8ml of 0.25% Bupivacaine and 2mg dexamethasone on each side. Analgesic efficacy is compared between both groups. Total analgesic consumption in 24 hours is studied. Dose - 8ml of 0.25% Bupivacaine and 2mg Dexamethasone on each side Route of administration - Bilateral Superficial Cervical Plexus Block under USG guidance Total duration - 12 to 14 hours 
Comparator Agent  Local Wound Infiltration  Patients undergoing thyroidectomies will be into group B. Group B will receive Local Wound Infiltration with 10ml of 0.25% bupivacaine with 4mg dexamethasone before skin incision. Analgesic efficacy is compared between both groups. Total analgesic consumption in 24 hours is studied Dose - 10ml of 0.25% bupivacaine with 4mg dexamethasone Route of Administration - Local wound infiltration Duration - 4 to 6 hours 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA I to III patients posted for thyroidectomies
2. Aged between 20 to 60 years.  
 
ExclusionCriteria 
Details  1. Patient refusal
2. Patients with history or allergy to local anaesthetics
3. Mentally retarded patients
4. Local infection at the site of procedure
5. Patients with history of chronic analgesic use
6. Patients with huge thyroid swellings
7. Patients with malignant thyroid swellings 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of superficial cervical plexus block with that of local wound infiltration.

To compare the duration of action of superficial cervical plexus block with that of local wound infiltration. 
Vitals will recorded every 5 mins for the first 20 mins and then every 30 mins till the end of the surgery. Postoperatively, pain assessment will be done using Visual Analog Scale (VAS) at 1 hour after
extubation, 2nd hour, 3rd hour, 6th hour, 12th hour, 24th hour.

 
 
Secondary Outcome  
Outcome  TimePoints 
To observe for any postoperative complications.

Total analgesic consumption in 24 hours. 
First 24 hours monitoring 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   26/02/2024 
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="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  
Pain after thyroid surgeries is considered to be of moderate intensity and short duration.
Patient may experience sore throat, odynophagia, burning sensation in the throat, nausea and vomiting which may be cause by the surgical procedure or due to endotracheal tube.
Usually, multimodal analgesia is tried for post operative patients. Non-steroidal anti-inflammatory drugs (NSAIDs) may not be effective for postoperative pain and opioids cause post operative nausea and vomiting. 
So, recent studies concerning post thyroidectomy analgesia are focused on the efficacy of regional techniques.
Local anaesthetic wound infiltration (LWI), bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus blocks are tried with variable results. All these methods share the same principal of cervical plexus sensory blockade at different levels.
LWI is a simple method of post operative pain management, because of its simplicity, safety and low cost. Its efficacy in decreasing post operative pain and analgesic consumption is demonstrated in many procedures like cholecystectomy, hysterectomy and hernia repair.
BSCPB is a popular regional anaesthesia used in thyroidectomy because of its feasibility and efficacy. Use of ultrasound guidance (US) facilitates the procedure by real-time visualisation of anatomical structures and needle movements and increases the chances of successful blockade while decreasing the rate of complications.
So, in this study, we are planning to compare the effectiveness of US guided BSCPB with that of LWI using bupivacaine dexamethasone mixture for post operative analgesia following thyroidectomies. In our study an effort has been made to compare analgesic efficacy and duration of analgesia of superficial cervical plexus block with that of local wound infiltration.
 
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