| CTRI Number |
CTRI/2025/01/079411 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [Nerve Block ] |
| Study Design |
Other |
|
Public Title of Study
|
To compare the analgesic effects and duration of rescue analgesia post operatively in superficial cervical plexus block versus greater auricular nerve block in mastoid surgeries. |
|
Scientific Title of Study
|
Comparison of superficial cervical plexus block versus greater auricular nerve block on post operative analgesia in mastoid 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 |
Priyanka Raghunath Salunkhe |
| Designation |
Junior Resident |
| Affiliation |
D Y Patil medical college and hospital kolhapur |
| Address |
Department of Anaesthesia D Y Patil medical college and Hospital Kolhapur
Kolhapur
MAHARASHTRA
416001
India |
| Phone |
9765929262 |
| Fax |
|
| Email |
salunkhepriyanka96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Bawdekar |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil medical college and hospital kolhapur |
| Address |
Department of Anaesthesia D Y Patil medical college and Hospital Kolhapur
Kolhapur
MAHARASHTRA
416001
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Bawdekar |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil medical college and hospital kolhapur |
| Address |
Department of Anaesthesia D Y Patil medical college and Hospital Kolhapur
MAHARASHTRA
416001
India |
| Phone |
9448866819 |
| Fax |
|
| Email |
rashbawdekar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil medical college hospital and research institute kadamwadi kolhapur Maharashtra India PIN-416003 |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Salunkhe |
| Address |
Department of Anaesthesia D Y Patil medical college and Hospital Kolhapur
PIN 416003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rashmi Bawdekar |
DR. D.Y.Patil hospital and research center |
P.G Department of anesthesiology
D.Y.Patil medical college hospital and research center kolhapur
Kolhapur
MAHARASHTRA |
9448866819
rashbawdekar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, D.Y. Patil medical college kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
superficial cervical plexus block versus greater auricular nerve block |
Both Group 1 and Group 2 will be given 10ml of mixture of local anesthetics and the duration of analgesia and requirement of rescue analgesia are compared between both the blocks. |
| Intervention |
superficial cervical plexus block versus greater auricular nerve block |
After completion of mastoid surgery before extubation, patients will be randomly assigned into two groups based on computer generated randomisation. Group 1 will receive superficial cervical plexus block and
Group 2 will receive greater auricular nerve block.
9.5ml of 0.25%Inj.bupivacaine+0.5mlInj.Dexamethasone(2mg)-total 10 ml of drug will be used for both the groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing mastoid surgeries under general anaesthesia
2. Patients belonging to ASA grade 1 & 2
3. Aged 18years to 65years of all gender |
|
| ExclusionCriteria |
| Details |
1.Patient refusal for procedure
2. Known or suspected allergy to any of the drug
3.Psychiatric illness
4.Facial nerve palsy
5.Pregnancy
6. Obesity
7. Anatomical lesions around the neck
8. Previous surgery or radiation therapy to the neck |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post operative analgesic efficacy using (VAS score),duration and requirement of rescue analgesia in Superficial cervical plexus block and Greater auricular nerve block in mastoid surgeries.
|
From post operative Upto 1st 8hours, 1hourly
from 8hours to 24hours, 2 hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the requirement of rescue analgesia in first 24hours post operatively in superficial cervical plexus block versus greater auricular nerve block. |
first 24 hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/02/2025 |
| 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 Yet Recruiting |
| 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
|
Regional nerve blocks are known to increase the duration of analgesia in any surgery. They also reduce the requirement of repeated oral and intravenous analgesics and their side effects. Superficial cervical plexus block and greater auricular nerve block are widely used analgesic block for mastoid surgeries. In our study we choose to compare analgesic efficacy, duration of post operative analgesic and requirement of analgesics in first 24hrs of both blocks in mastoid surgeries.null hypothesis- In mastoid surgeries there is no difference in analgesic efficacy, duration of analgesia and requirement of rescue analgesics in superficial cervical plexus block and greater auricular nerve block
|