| CTRI Number |
CTRI/2025/11/096827 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of anaesthesia techniques in patients posted for thyroid surgeries |
|
Scientific Title of Study
|
Randomised controlled trial comparing ultrasound guided cervical plexus block with general anaesthesia for elective Hemi-Thyroidectomy surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narender Bhandari |
| Designation |
Assistant Professor |
| Affiliation |
RIMS ADILABAD |
| Address |
Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad, Rickshaw colony, Adilabad, Telangana, 504001
Adilabad TELANGANA 504001 India |
| Phone |
9701853153 |
| Fax |
|
| Email |
narenderbhandari77@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Belli Yashaswi |
| Designation |
Assistant Professor |
| Affiliation |
RIMS ADILABAD |
| Address |
Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad, Rickshaw colony, Adilabad, Telangana, 504001
Adilabad TELANGANA 504001 India |
| Phone |
7382945043 |
| Fax |
|
| Email |
yashaswini.belli@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Belli Yashaswi |
| Designation |
Assistant Professor |
| Affiliation |
RIMS ADILABAD |
| Address |
Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad,Rickshaw colony, Adilabad, Telangana, 504001
Adilabad TELANGANA 504001 India |
| Phone |
7382945043 |
| Fax |
|
| Email |
yashaswini.belli@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RIMS ADILABAD |
| Address |
Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad,Rickshaw colony, Adilabad, Telangana, 504001 |
| Type of Sponsor |
Government 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 Yashaswi |
RIMS ADILABAD |
Department of Anesthesiology, PMSSY OT Complex, Second floor, RIMS Adilabad,Rickshaw colony, Adilabad, Telangana, 504001 Adilabad TELANGANA |
7382945043
yashaswini.belli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee RIMS Adilabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cervical plexus block |
Bilateral superficial plexus ipsilateral deep cervical plexus block |
| Comparator Agent |
General anaesthesia |
Propofol, vecuronium, nalbuphine, midazolam |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients
Elective surgeries fit for general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patient with IHD,CAD,COPD,ILD, ASTHMA
Obese patients
Difficult airway and intubation
Children and pregnant patients
Fearful and uncooperative patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequacy of block, duration of analgesia |
30 min after surgery, 2 hours, 6 hrs and 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia |
6 hours |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
21/11/2025 |
| 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="0" 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
|
AIM and OBJECTIVES The aim of this study is to compare the Ultrasound guided cervical plexus block with general anesthesia for elective Hemi-thyroidectomy surgeries in terms of: Intraoperative hemodynamic stability ,Patient satisfaction Post operative analgesia requirement , PONV and antiemitic requirement Time of postoperative revival Duration of recovery stay INTRODUCTION Thyroid surgery is one of the frequently performed surgical procedures.1 Both general anesthesia (GA) and cervical plexus anesthesia (CPA) can be used for thyroidectomy surgeries. The use of regional anaesthesia in thyroid surgery remains controversial. Cervical Plexus Blocks(CPB) are regional anesthesia techniques that can be used alone or in combination with GA for various head and neck surgeries. CPB alone can provide effective anaestesia in pain relief for procedure involving the anterior-lateral neck, upper shoulder and posterior scalp. In our study, we are comparing CPB with GA for anterior-lateral neck surgery hemi-thyroidectomy. Unilateral deep cervical plexus block and bilateral superficial block are given for hemi-thyroidectomy surgeries. Ultrasound guided technique has the advantages over the landmark based technique include the ability to visualise the spread of local anesthetic in correct plane, which therefore increases the success rate. It also avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures. Regional blocks in thyroid surgeries has the advantage to monitor voice and breathing during surgery. |