| CTRI Number |
CTRI/2025/02/080227 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the pain relieving effect of two drugs given via regional method versus when given intravenously in patients undergoing ear surgeries. |
|
Scientific Title of Study
|
To assess the efficiency of Greater Auricular Nerve Block for Post Operative Analgesia in patients underoing Tympanomastoid Surgeries under General Anaesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niveditha Kishore Srinivasan |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
09082215575 |
| Fax |
|
| Email |
niveditha2899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th floor, Hi- tech building, Dr DY Patil college, hospital and research centre, Sant Tukaram Nagar, Pimpri Pune. 411018 |
|
|
Primary Sponsor
|
| Name |
Niveditha Kishore Srinivasan |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [self] |
|
|
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 |
| NIVEDITHA KISHORE SRINIVASAN |
DR. D.Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr. D.Y. Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9082215575
niveditha2899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Greater Auricular Nerve Block with 5ml of 0.25% inj Bupivacaine |
Greater Auricular Nerve Block will be given with 5ml of 0.25% inj Bupivacaine prior to extubation |
| Comparator Agent |
Intravenous inj. Diclofenac 75mg |
Inj Diclofenac 75mg will be given intravenously prior to extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) American Society of Anaesthesiology (ASA) grade I and II
2) Hemodynamically stable patients with all routine investigations within the normal limits.
3) Patients who give informed written consent and are willing to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1) Patients with bleeding disorders or on anticoagulants
2) Patients with facial nerve palsy
3) Infection/trauma/skin conditions at the site of block
4) History of allergy to any of the drugs being used under study
5) Patients unable to comprehend VAS/ known neurological/psychiatric illness
6) Unwilling patients
7) ASA 3 or above |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Greater Auricular Nerve Block for Post Operative Analgesia in Tympanomastoid surgeries |
Haemodynamic monitoring after giving the block-
1) At the end of surgery
Post Operatively at-
2) 0 minutes
3) 30 minutes
3) 1 hour
4) 6 hours
5) 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Greater Auricular Nerve Block for Post Operative Analgesia in Tympanomastoid surgeries |
Post Operative Visual Analogue Score will be assessed at-
1) 0 minutes
2) 30 minutes
3) 1 hour
4) 6 hours
5) 12 hours
If VAS score is more than 4, rescue analgesia will be given |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="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
|
It is a Prospective, Randomized Control Trial to assess post operative analgesia after giving Greater Auricular Nerve block in Tympanomastoid surgeries.Parameters observed: 1) Heart rate (HR), Systolic blood pressure(SBP), diastolic blood pressure(DBP), Mean Arterial Pressure(MAP), Oxygen saturation (SpO2) post operatively 2) Time between closure and first rescue analgesia 3) Post operative VAS 4) Any postoperative side effect or complications 5) Total requirement of rescue analgesia post operatively over 12 hours At any time when VAS is greater than 4, injection Paracetamol 1g intravenous will be given. |