| CTRI Number |
CTRI/2024/01/061525 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING TWO DIFFERENT TECHNIQUES NAMED INTERMEDIATE AND SUPERFICIAL CERVICAL PLEXUS BLOCK TO PREVENT PAIN AFTER THYROID SURGERY |
|
Scientific Title of Study
|
EVALUATION OF ULTRASOUND GUIDED INTERMEDIATE VERSUS SUPERFICIAL CERVICAL PLEXUS BLOCK FOR POST OPERATIVE ANALGESIA 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 Prasanna Vadhanan |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL |
| Address |
FIRST FLOOR
DEPARTMENT OF ANAESTHESIOLOGY
VINAYAKA MISSIONS MEDICAL COLLEGE
KEEZHAKASAKUDI MEDU KOTTUCHERRY KARAIKAL PUDHUCHERRY
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Vadhanan |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
VINAYAKA MISSIONS MEDICAL COLLEGE,
KEEZHAKASAKUDI MEDU, KOTTUCHERRY, KARAIKAL
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ASWIN DIVAKAR S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
VINAYAKA MISSIONS MEDICAL COLLEGE,
KEEZHAKASAKUDI MEDU, KOTTUCHERRY, KARAIKAL
FIRST FLOOR
DEPARTMENT OF ANAESTHESIOLOGY
VINAYAKA MISSIONS MEDICAL COLLEGEAND HOSPITAL
KEEZHAKASAKUDIMEDU, KOTTUCHERRY,
KARAIKAL
Karaikal
PONDICHERRY
DR ASWIN DIVAKAR
India |
| Phone |
9042686809 |
| Fax |
|
| Email |
dr.aswindivakar@gmail.com |
|
|
Source of Monetary or Material Support
|
| VINAYAKA MISSIONS RESEARCH FOUNDATION, SALEM, TAMILNADU |
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSIONS RESEARCH FOUNDATION |
| Address |
NH 47, SANKARI MAIN ROAD, SALEM 636308 |
| Type of Sponsor |
Research institution |
|
|
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 ASWIN DIVAKAR |
VINAYAKA MISSIONS MEDICAL COLLEGE |
FIRST FLOOR
DEPARTMENT OF ANAESTHESIOLOGY
KEEZHAKASAKUDIMEDU, KOTTUCHERRY,
KARAIKAL
Karaikal
PONDICHERRY |
9042686809
dr.aswindivakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTERMEDIATE CERVICAL PLEXUS BLOCK |
Intermediate cervical
plexus block, the injection Bupivacaine is made between the investing layer
of the deep cervical fascia and the prevertebral fascia |
| Intervention |
SUPERFICIAL CERVICAL PLEXUS BLOCK |
superficial cervical plexus
block, Injection bupivacaine is injected superficially to the deep
cervical fascia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA physical status I–II adult patients undergoing elective thyroid surgery under general anaesthesia
2 Patient willing to give consent
|
|
| ExclusionCriteria |
| Details |
1 Preoperative medication included opioid or non-opioid analgesics,
Corticosteroids, or non-steroidal anti-inflammatory drugs.
Coagulation disorders,
Pregnancy,
2 Age less than 18 years,
3 Patient refusal
4 Emergency re-operation within the first 24 hours
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale (VAS) scores |
2 HOURS, 4 HOURS, 6 HOURS, 12 HOURS, 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative analgesic requirements
length of hospital stay
Incidence of postoperative nausea and vomiting |
0-24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
•Pain after thyroid surgery is
considered to be of moderate intensity with up to 90% of the patients requiring
narcotics on the first postoperative day and is of short duration. With
improvements in the operative techniques for thyroidectomy, the surgical
complications like hoarseness of voice and hypocalcemia have been minimized. Pain has now emerged as
a significant problem in the postoperative period. Intermediate cervical
plexus block (CPB) is a new procedure whose analgesic efficacy compared to
superficial cervical plexus block is yet to be established. If we can control early
postoperative pain and avoid the nausea and vomiting that are induced by
opioids, patients can achieve a good quality of analgesia after thyroidectomy.
|