| CTRI Number |
CTRI/2026/03/105750 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Postoperative Pain Control in Thyroid Surgery: A Study of Bupivacaine With and Without Dexmedetomidine |
|
Scientific Title of Study
|
Analgesic outcomes of Bupivacaine alone versus Bupivacaine with Dexmedetomidine in Bilateral Superficial cervical plexus block in Thyroid surgeries |
| 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 Senthil M |
| Designation |
PROFESSOR |
| Affiliation |
Vinayaka missions kirupananda variyar medical college and hospital |
| Address |
Room no 14
Department of Anaesthesiology
Vinayaka missions kirupananda variyar medical college and hospital chinnasiragapadi ariyanoorsalem.
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail,com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil M |
| Designation |
PROFESSOR |
| Affiliation |
Vinayaka missions kirupananda variyar medical college and hospital |
| Address |
Room no 14
Department of Anaesthesiology
Vinayaka missions kirupananda variyar medical college and hospital chinnasiragapadi ariyanoor salem.
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C ROHITH KUMAR |
| Designation |
POST GRADUATE |
| Affiliation |
Vinayaka missions kirupananda variyar medical college and hospital |
| Address |
Room no 14
Department of Anaesthesiology
Vinayaka missions kirupananda variyar medical college and hospital chinnasiragapadi ariyanoor salem.
Mahbubnagar
TELANGANA
636308
India |
| Phone |
8978707048 |
| Fax |
|
| Email |
rohithchintalapally@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical college and Hospital chinnasiragapadi Ariyanoor Salem district 636308 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar medical college and hospital Salem |
| Address |
Room no:14
Department of Anaesthesiology
Vinayaka Missions Kirupananda Variyar medical college and hospital Salem 636308 Tamilnadu India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR C ROHITH KUMAR |
vinayaka missions kirupananda variyar medical college and hospital |
Room no 14
Department of Anaesthesiology
Vinayaka missions kirupananda variyar medical college and hospital,chinnasiragapadi,ariyanoor,salem.
Salem
TAMIL NADU |
8978707048
rohithchintalapally@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine 0.5 percent |
Superficial cervical plexus block with 0.5 Percent bupivacaine 19 ml diluted with 1 ml normal saline administering 10 ml on each side bilaterally The block will be performed under ultrasound guidance after induction of general anesthesia by a senior anesthetist Duration of intervention will be approximately 10 minutes Intraoperative monitoring will include heart rate blood pressure SpO2 and EtCO2 at regular intervals Postoperative pain will be assessed using the Visual Analog scale for every 2 hours till 24 hours Analgesic consumption time to first rescue analgesia adverse effects and patient satisfaction will be recorded for 24 hours postoperatively |
| Comparator Agent |
Bupivacaine 0.5percent with Dexmedetomidine |
Superficial cervical plexus block with 0.5percent bupivacaine 19.5 ml with 0.5 ml(50 micrograms) Dexmedetomidine administering 10 ml on each side bilaterally The block will be performed under ultrasound guidance after induction of general anesthesia by a senior anesthetist.Intraoperative monitoring will include heart rate blood pressure SpO2 and EtCO2 at regular intervals. Postoperative pain will be assessed using the Visual analog scale for every 2hrs till 24 hours. Analgesic consumption time to first rescue analgesia adverse effects and patient satisfaction will be recorded for 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients age 18 to 65 years undergoing elective thyroidectomy
2.American society of Anaesthesiologists physical status I or II
3.Written informed consent provided |
|
| ExclusionCriteria |
| Details |
1.Allergy to study drugs
2.Coagulopathy or bleeding disorders
3.Chronic opioid use or substance abuse
4.Severe hepatic renal or cardiovascular disease Pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Prolonged Duration of analgesia
2.Stable hemodynamic status
3.Lower post operative pain scores |
After administering block intraoperative haemodynamic monitoring postoperative pain will assessed using visual analog scale for every 2 hours till 24 hours and analgesic consumption Time to first rescue analgesia Adverse effects Patient satisfaction will be recorded till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduce analgesic consumption
2.High patient satisfaction
3.Acceptable safety profile |
After administering block Intraoperative haemodynamic monitoring postoperative pain will assessed using visual analog scale for every 2 hours till 24 hour & analgesic consumption Time to first rescue analgesia Adverse effects Patient satisfaction will be recorded till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/04/2026 |
| 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
|
This prospective randomized comparative study aims to evaluate the analgesic outcomes of bilateral superficial cervical plexus block using bupivacaine 0.5Percent alone versus bupivacaine 0.5Percent with dexmedetomidine in patients undergoing elective thyroid surgery under general anesthesia. After induction an ultrasound guided superficial cervical plexus block will be performed. Postoperative pain will be assessed using the visual analogue scale and the duration of analgesia Time to first rescue analgesic Total analgesic requirement Hemodynamic parameters and Adverse effects will be recorded. The study seeks to determine whether the addition of dexmedetomidine enhances the quality and duration of postoperative analgesia compared to bupivacaine alone. |