| CTRI Number |
CTRI/2020/02/023300 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
03/01/2021 |
| 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
|
COMPARISON OF PAIN RELIEF OF ROPIVACAINE WITH OR WITHOUT ADJUVANT IN BILATERAL SUPERFICIAL CERVICAL PLEXUS BLOCK IN THYROIDECTOMY SURGERIES IN POST OPERATIVE PERIOD |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF POST OPERATIVE ANALGESIC EFFICACY OF BILATERAL SUPERFICIAL CERVICAL PLEXUS BLOCK WITH 0.25% ROPIVACAINE VERSUS 0.25% ROPIVACAINE WITH DEXMEDETOMIDINE 0.5 mcg/kg FOR THYROIDECTOMY UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kriti Lakhina |
| Designation |
Postgraduate student |
| Affiliation |
Jawahar Lal Nehru Medical College, Ajmer |
| Address |
Department of Anaesthesiology, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
09999971517 |
| Fax |
|
| Email |
kriti.lakhina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena Jain |
| Designation |
Senior Professor and guide |
| Affiliation |
Jawahar Lal Nehru Medical College, Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
09414008666 |
| Fax |
|
| Email |
drneenaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neena Jain |
| Designation |
Senior Professor and guide |
| Affiliation |
Jawahar Lal Nehru Medical College, Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
09414008666 |
| Fax |
|
| Email |
drneenaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical College, Ajmer, Rajasthan, India-305001 |
|
|
Primary Sponsor
|
| Name |
JLN MEDICAL COLLEGE AJMER |
| Address |
Department of Anaesthesiology, JLN Medical College, Ajmer, Rajasthan |
| 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 Kriti Lakhina |
JLN Medical College |
Department of Anaesthesiology, JLN Medical College, Ajmer
Ajmer
RAJASTHAN |
09999971517
kriti.lakhina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, JLN Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E07||Disorders of thyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% isobaric ropivacaine alone and in combination with dexmedetomidine for bilateral superficial cervical plexus block |
Compare the duration of analgesia and duration of study is around 1 year |
| Intervention |
BILATERAL SUPERFICIAL CERVICAL PLEXUS BLOCK |
Post-operative analgesic efficacy is assessed and duration of study is around 1 year. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing thyroid surgery under general anaesthesia
Patient age between 16 – 60 years
ASA (American Society of Anaesthesiologists) physical status I and II
|
|
| ExclusionCriteria |
| Details |
Age < 16 and > 60 years
ASA physical status III, IV, V and VI.
Patients not willing to participate in the study
Patient with a known history of sensitivity and contraindications to drugs used
Patients with a known history of chronic analgesic consumption
Patients with a known history of psychiatric illness
Patients non-euthyroid at the time of surgery.
Patients with known coagulopathy
Infection at the site of block
Patients with substernal goitre
Patients with stridor or respiratory compromise
Patients with thyroid malignancy requiring block dissection
Patients having advanced heart block
Patients with severe ventricular dysfunction, and/or hypovolemia
Patients with co-mobidities like diabetes mellitus or chronic hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia |
Duration of study is around 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total consumption of analgesic in 24h
2. Post-operative nausea and vomiting
3. Adverse effects like hematoma, intravascular injections, local anaesthetic toxicity, bradycardia, hypotension and sedation |
Duration of study is around 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2020 |
| Date of Study Completion (India) |
01/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study is to compare ropivacaine with or without dexmedetomidine in thyroid surgeries under general anaesthesia with respect to:
Primary outcome: Duration of analgesia
Secondary outcome: 1. Total consumption of analgesic in 24h 2. Post-operative nausea and vomiting 3. Adverse effects like hematoma,
intravascular injections, local anaesthetic toxicity, bradycardia, hypotension
and sedation |