| CTRI Number |
CTRI/2025/03/081547 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| 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
|
A clinical trial to study the effect of two drugs - Lignocaine and Ropivacaine used for giving local anesthesia in ear surgeries |
|
Scientific Title of Study
|
Efficacy and Safety profile of 2% Lignocaine versus 0.5% Ropivacaine as local anaesthetic agent in middle ear surgeries in a tertiary care centre Chengalpattu district - A Single Blind 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 |
Swathi S |
| Designation |
Postgraduate |
| Affiliation |
Karpaga vinayaga institue of medical sciences and research centre |
| Address |
Girls hostel Room No F6, Department of ENT, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, Chinna kolambakkam, palayanoor, Maduranthakam,
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9043661179 |
| Fax |
|
| Email |
swathi2010s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Mohanakarthikeyan |
| Designation |
Professor |
| Affiliation |
Karpaga vinayaga institue of medical sciences and research centre |
| Address |
Department of ENT, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, chinna kolambakkam, palayanoor, Maduranthakam,
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8056802061 |
| Fax |
|
| Email |
karthient@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi S |
| Designation |
Postgraduate |
| Affiliation |
Karpaga vinayaga institue of medical sciences and research centre |
| Address |
Girls hostel room no F6,Department of ENT, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, chinna kolambakkam, palayanoor, Maduranthakam,
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9043661179 |
| Fax |
|
| Email |
swathi2010s@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of ENT, Karpaga Vinayaga Institute of Medical Sciences and Research Centre, GST Road, chinna kolambakkam, palayanoor, Maduranthakam, Tamil nadu, India- 603308 |
|
|
Primary Sponsor
|
| Name |
SWATHI S |
| Address |
Karpaga vinayaga Institute of medical sciences and research centre, GST Road, chinna kolambakkam, palayanoor, Maduranthakam, Tamilnadu, India- 603308 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Swathi S |
Karpaga vinayaga Institute of medical sciences and research centre |
Girls hostel room no F6, Department of ENT, GST Road, chinna kolambakkam, palayanoor, Maduranthakam, chengalpattu 603308
Kancheepuram
TAMIL NADU |
9043661179
swathi2010s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 3||Administration, (3) ICD-10 Condition: H652||Chronic serous otitis media, (4) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (5) ICD-10 Condition: H720||Central perforation of tympanic membrane, (6) ICD-10 Condition: H800||Otosclerosis involving oval window, nonobliterative, (7) ICD-10 Condition: H742||Discontinuity and dislocation of ear ossicles, (8) ICD-10 Condition: H744||Polyp of middle ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5% ROPIVACAINE |
0.5% Ropivacaine (Inj.0.5%ROPIN) with epinephrine (Inj.VASOCON) in the ratio 1:40,000 (20 ml of 0.5% Ropivacaine with 0.5 ml of epinephrine 1:1000) at a dose of Ropivacaine 3-4mg/kg .
|
| Comparator Agent |
2% LIGNOCAINE |
2% Lignocaine with epinephrine in ratio 1:200000 (Inj.2% LOX with ADRENALINE), at a dose of Lignocaine 1.3-3mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with middle ear pathologies planned for surgeries like tympanoplasty, Stapedectomy, mastoidectomy, myringotomy, grommet insertion.
Patients those who provided informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Previous history of Allergic reactions to Amide type local anaesthetics
2.History of severe cardiac arrythmias, severe liver or renal disorders, neurological disorders
3.Pregnancy and breastfeeding mothers
4. Cognitive barriers
|
|
|
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 |
| Postoperative Analgesia using Visual Analog Scale |
Every hour till first 8 hours during the postoperative recovery period, Pain will be assessed using Visual Analog Scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset of action of local anaesthesia by pin prick method |
time calculated from completion of administration of local anesthesia to onset of anesthesia |
| duration of action of local anaesthesia assessed by return of sensation in targeted area |
in first 8 hours of postoperative period |
| time of 1st rescue analgesic given postoperatively |
in the first 8 hours of postoperative period |
| surgeon satisfaction by Likert scale |
|
| patient satisfaction with LOWA satisfaction with anesthesia scale |
|
| hemodynamic stability by recording the vitals during the intraoperative period |
|
adverse effects like Nausea, vomiting, Bradycardia, Hypotension, Dizziness, Confusion, Respiratory depression, seizures, Cardiac arrest will be recorded
|
|
|
|
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)
|
05/03/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study
is a randomized, single blind, single-centre trial comparing the efficacy and safety
profile of 0.5% Ropivacaine and 2% Lignocaine as local anaesthetic in middle
ear surgeries in 80 patients that will be conducted in Single tertiary care center
in Chengalpattu district, India. The primary outcome measure will be duration
of Postoperative analgesia. The secondary outcomes will be onset of action, duration
of action. time of 1st rescue analgesic given postoperatively, surgeon satisfaction,
patient satisfaction, hemodynamic
stability, adverse effects |