| CTRI Number |
CTRI/2018/02/011899 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of a pain reducing agent(bupivacaine)adding another medicine(dexamethasone) which favours the action of bupivacaine versus bupivacaine alone, for pain relief injected near a nerve in the neck which is responsible for pain after a type of ear related surgery |
|
Scientific Title of Study
|
Comparative evaluation of Bupivacaine 0.25% with Dexamethasone 2mg versus Bupivacaine 0.25% alone in greater auricular nerve block for post-operative analgesia in mastoid surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini D |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college and hospital |
| Address |
Department of Anaesthesiology, KMC, Manipal
Manipal, udupi district, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
09986910818 |
| Fax |
|
| Email |
nandini.nd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Bawdekar |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical college and hospital |
| Address |
Department of Anaesthesiology, KMC, Manipal
Manipal, udupi district, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
09448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Bawdekar |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical college and hospital |
| Address |
Department of Anaesthesiology, KMC, Manipal
Manipal, udupi district, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
09448866819 |
| Fax |
|
| Email |
rashbawdekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Kasturba College and Hospital, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
PG Thesis fund KMC Manipal |
| Address |
kasturba medical college and hospital, Manipal, udupi district, Karnataka-576104 |
| 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 Nandini D |
Kasturba Medical College and Hospital |
Department of Anaesthesiology, OT complex, 1st floor, Manipal
Udupi
KARNATAKA |
09986910818
nandini.nd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Age group between 18 and 65years of either gender belonging to ASAPS 1 or 2
undergoing Mastoid surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D |
Greater auricular nerve block with 9.5ml of bupivacaine 0.25% and dexamethasone 2mg i.e 0.5ml |
| Comparator Agent |
Group S |
Greater auricular nerve block with 9.5ml of bupivacaine 0.25% and 0.5ml of normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASAPS 1 or 2
undergoing Mastoid surgery |
|
| ExclusionCriteria |
| Details |
Bleeding disorders
On anticoagulant drugs
Facial or other nerve palsy
Infection,trauma, scar or sinuses at the site of block
Known hypersensitivity to local anaesthetic drug
Pregnant and lactating women
Unable to speak or understand verbal command and VAS
Unwilling to participate in the study
Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia |
first 8 hours, hourly and then every 2 hours for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| requirement of rescue analgesics |
every hour for first 8 hours and every 2 hours for 24 hours till VAS 4 or more |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2017 |
| Date of Study Completion (India) |
18/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a prospective double blind randomised controlled study. It is a comparative evaluation of bupivacaine 0.25% with dexamethasone 2mg versus bupivacaine 0.25% alone in greater auricular nerve block for post-operative analgesia in mastoid surgery. Primary outcome is to measure the duration of analgesia in hours and secondary outcome is the requirement of rescue analgesics as per visual analogue scale of score 4 or more in the post-operative period.
conclusion - Dexamethasone as an adjuvant to bupivacaine in greater auricular nerve block significantly increases the duration of analgesia and reduces the need for rescue analgesics without any complications. |