| CTRI Number |
CTRI/2022/10/046296 [Registered on: 10/10/2022] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| 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
|
Regional nerve blocks (local anaesthesia)in adjunct to general anaesthesia versus general anaesthesia alone for faciomaxillary surgeries a randomised study |
|
Scientific Title of Study
|
Regional nerve blocks in adjunct to general anaesthesia versus general anaesthesia alone for faciomaxillary surgeries-a randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithyashree Singh |
| Designation |
Post graduate medical student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka 560002
Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9686672181 |
| Fax |
|
| Email |
Nithyashreesingh.8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandhya K |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
sandyaraghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandhya K |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka 560002
Koppal
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
sandyaraghu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute,KR market , 560002, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Nithyashree Singh |
| Address |
Department of Anaesthesiology,Bangalore medical college and research institute ,KR market,560002, Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sandhya K |
Department of Anaesthesiology,Bangalore medical college and research institute ,KR market,Bangalore 560002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nithyashree Singh |
Bangalore medical college and research institute |
Department of Anaesthesiology,Bangalore medical college and research institute ,KR market,Bangalore 560002
Bangalore
KARNATAKA |
9686672181
nithyashreesingh.8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Regional nerve blocks |
Regional nerve block is given in one group along with general anaesthesia while only general anaesthesia is given in other group |
| Intervention |
Regional nerve blocks along with general anaesthesia |
Regional nerve block with 0.2% ropivacaine along with general anaesthesia is given in one group while only general anaesthesia is given in one group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patients willing to give written consent
2) patients aged 18-60years of both genders
3) patients scheduled for elective faciomaxillary surgeries under general anaesthesia
4) ASA I and ASA II patients |
|
| ExclusionCriteria |
| Details |
1) patients with ASA 3 and ASA 4
2) Pregnant women
3) patients with known allergy to study drug
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the intraoperative analgesic effect of regional nerve blocks upto 24hours after block
Requirement of rescue analgesia postoperatively |
Time of rescue analgesia postoperatively upto 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To minimise the side effects of postoperative opioids |
6th hour , 12th hour and 24hours after surgery |
|
|
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)
|
13/10/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We compare the intraoperative and postoperative analgesia in two groups where one group receives regional nerve blocks and general anaesthesia while other group receives only general anaesthesia for faciomaxillary surgeries. |