| CTRI Number |
CTRI/2025/10/096303 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| 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
|
Postoperative analgesic efficacy of 0.25% Ropivacaine with Dexmedetomidine versus Dexamethasone as adjuvants in Bilateral superficial cervical plexus block for Thyroidectomy surgery under general anesthesia in a tertiary care center in Wayanad. |
|
Scientific Title of Study
|
Postoperative analgesic efficacy of 0.25% Ropivacaine with Dexmedetomidine versus Dexamethasone as adjuvants in Bilateral superficial cervical plexus block for Thyroidectomy surgery under general anesthesia-Randomized controlled trial |
| 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 Drisya pv |
| Designation |
PG Resident |
| Affiliation |
Dr Moopen’s Medical College, Wayanad |
| Address |
Department of Anesthesiology,
7th Floor,
Dr Moopen’s Medical College,
Naseera Nagar,
Meppadi,
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
7907984067 |
| Fax |
|
| Email |
drisyapv2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Tegginamath |
| Designation |
Professor and HOD Department of Anaesthesiology |
| Affiliation |
Dr Moopen’s Medical College, Wayanad |
| Address |
Department of Anesthesiology
Dr Moopen’s Medical College,
7th Floor,
Naseera Nagar,
Meppadi,
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
9243507325 |
| Fax |
|
| Email |
shraddhakrupa27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Tegginamath |
| Designation |
Professor and HOD Department of Anaesthesiology |
| Affiliation |
Dr Moopen’s Medical College, Wayanad |
| Address |
Department of Anesthesiology
Dr Moopen’s Medical College,
7th Floor,
Naseera Nagar,
Meppadi,
Wayanad
Wayanad
KERALA
673577
India |
| Phone |
9243507325 |
| Fax |
|
| Email |
shraddhakrupa27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Moopen’s Medical College wayanad |
|
|
Primary Sponsor
|
| Name |
Dr Moopen’s Medical College, Wayanad |
| Address |
Dr Moopen’s Medical College
Naseera Nagar,Meppadi po,
Wayanad, kerala 673577 |
| 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 Drisya pv |
Dr Moopen’s Medical College |
Department of Anaesthesiology Dr Moopen’s Medical College
Naseera Nagar
Meppadi, Wayanad
Kerala
Wayanad
KERALA |
7907984067
drisyapv2020@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients undergoing thyroidectomy surgery under general anesthesia satisfying inclusion and exclusion criteria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilateral superficial cervical plexus block using ropivacaine with dexamethasone |
To enhance and prolong the analgesic effect of ropivacaine, adjuvants such dexamethasone (dexona) are increasingly used.Dexamethasone, a corticosteroid, is another commonly used adjuvant known to extend block
duration, possibly through anti-inflammatory effects and modulation of nociceptive pathways.20ml of 0.25% ropivacaine with 4 mg Dexamethasone is used for block.More than 12 hrs is the expected duration of action. |
| Intervention |
Bilateral superficial cervical plexus block using ropivacaine with dexmedetomidine |
To enhance and prolong the analgesic effects of ropivacaine in superficial cervical plexus block adjuvants such as dexmedetomidine is increasingly used.dexmedetomidine is a alpha 2 adrenergic agonist has both analgesic and sedative properties.it has been shown to prolong the duration of nerve blocks and improve postoperative analgesia without significant respiratory depression.20 ml of 0.25% ropivacaine with 50 mcg dexmedetomidine is used for block.more than 12 hours is the expected duration of action. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective thyroidectomy surgery
Belonging to ASA Class 1&2 |
|
| ExclusionCriteria |
| Details |
Patients with altered cervical plexus anatomy
Coagulation disorders
Systemic infection and infection at injection site
History of allergy to local anesthetic agents |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Understand which among the two adjuvants offers superior postoperative analgesia,fewer complications and better patient satisfaction |
Time points used for Postoperative Analgesia comparison is zeroth hour( immediately after coming out of general anesthesia),2 hours ,6hours,12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total analgesic consumption within the twogroups |
Within the first 24 hours after surgery |
| To assess intraoperative hemodynamic stability in both groups |
Throughout the surgey |
| To compare the incidence of side effects/complications related to the block & adjuvants |
Within the first 24 hours after the surgery |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="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
|
Thyroidectomy,a common elective surgery,often results in significant postoperative pain,which can impact recovery and patient comfort.The bilateral superficial cervical plexus block(BSCPB) is commonly used as an adjunct to general anesthesia to reduce postoperative pain in thyroid surgeries.To enhance the efficacy and duration of analgesia,adjuvants like dexmedetomidine and dexamethasone are often added to local anesthetics such as ropivacaine. This randomized,single blinded,prospective,comparative study aims to evaluate and compare the analgesic efficacy of dexmedetomidine vs dexamethasoneas adjuvants to ropivacaine-based BSCPB in patients undergoing elective thyroidectomy under general anesthesia.The study will be conducted at Dr Moopens Medical College,Wayanad,over a period of 1.5 years,involving86 ASA I&II patients aged 18-60 years,randomized into two equal groups. The primary objective is to assess postopeartive pain using the Numerical Rating Scale(NRS) and determine the effectiveness of each adjuvant in prolonging analgesia and reducing the need for rescue analgesics. |