| CTRI Number |
CTRI/2025/08/093718 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two blocks for patients undergoing Thyroid surgery to reduce pain after surgery |
|
Scientific Title of Study
|
Comparison Of Ultrasound Guided Intermediate versus Superficial Cervical Plexus Block as an Adjuvant for patients undergoing Total Thyroidectomy under General Anaesthesia |
| 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 Sabapathy Appavoo V A |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU
636308
India |
| Phone |
09751585899 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabapathy Appavoo V A |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU
636308
India |
| Phone |
09751585899 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabapathy Appavoo V A |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU
636308
India |
| Phone |
09751585899 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals , Salem 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
| Address |
Chinnaseeragapadi, Salem 636308 |
| 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 Anagha Gopinath P |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
Room number 15 Department of Anaesthesia
Salem
TAMIL NADU |
9497336774
anagha774@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Comparison of ultrasound guided intermediate versus superficial cervical plexus block for patients undergoing total thyroidectomy under general anaesthesia |
Total of intraneural 2O ml of 0.25% INJ.Bupivacaine and 100 mcg Inj.Epinephrine given for intermediate Cervical plexus block as adjuvants for patients undergoing total thyroidectomy |
| Comparator Agent |
Comparison of ultrasound guided intermediate versus superficial cervical plexus block for patients undergoing total thyroidectomy under general anaesthesia |
Total of intraneural 2O ml of 0.25% INJ.Bupivacaine and 100 mcg Inj.Epinephrine given for superficial Cervical plexus block as adjuvants for patients undergoing total thyroidectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and 2
2.Patients giving valid informed consent
3.Elective thyroidectomy surgeries |
|
| ExclusionCriteria |
| Details |
1.ASA 3 and 4
2.Patient refusal
3.Patients with local infection at puncturing site
4.Patients posted for emergency surgeries
5.Patients allergic to local anaesthetic drugs
6.Age less than 18yrs and more than 60 yrs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate intraoperative requirements of opioids and other anaesthetic agents while using intermediate vs superficial cervical block as adjuvants for patients undergoing total thyroidectomy under general anaesthesia |
To evaluate intraoperative requirements of opioids and other anaesthetic agents while using intermediate vs superficial cervical block as adjuvants for patients undergoing total thyroidectomy under general anaesthesia for duration of 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare post-operative analgesic efficacy of intermediate vs superficial cervical plexus block in patients undergoing total thyroidectomy under general anaesthesia |
From 0 minutes after surgery to 24 hours post-operatively |
|
|
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 3 |
|
Date of First Enrollment (India)
|
26/08/2025 |
| 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="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 is a prospective randomised interventional comparitive clinical study comparing intermediate versus superficial cervical plexus block as adjuvants to patients undergoing total thyroidectomy under general anaesthesia by evaluating intraoperative requirements of opioids and other anaesthetic agents , also comparing post-operative analgesic efficacy. |