| CTRI Number |
CTRI/2022/11/047218 [Registered on: 11/11/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the pain after kidney stone surgery by using different drugs. |
|
Scientific Title of Study
|
“Comparison of analgesic efficacy of fentanyl versus dexmedetomidine as a additive to bupivacaine in erector spinae plane block in patients undergoing percutaneous nephrolithotomy under general anaesthesia.†:-A prospective randomised double blind 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 SIDDESHWARA |
| Designation |
POSTGRADUATE STUDENT, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SDMCMSH, MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
Dharwad
KARNATAKA
570009
India |
| Phone |
7204923895 |
| Fax |
|
| Email |
siddugp1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr IMRAN SHOLAPUR |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SDMCMSH, MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
Dharwad
KARNATAKA
570009
India |
| Phone |
9731047204 |
| Fax |
|
| Email |
drimransholapur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr IMRAN SHOLAPUR |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SDMCMSH, MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
Dharwad
KARNATAKA
585325
India |
| Phone |
7204923895 |
| Fax |
|
| Email |
drimransholapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Sdm college of medical science |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR,SATTUR COLONY, DHARWAD,KARNATAKA 5800O9 |
| Type of Sponsor |
Private medical college |
|
|
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 SIDDESHWARA |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, 2nd floor SDMCMSH, MANJUSHREE NAGAR,SATTUR,DHARWAD - 570009
Dharwad
KARNATAKA |
7204923895
siddugp1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM COLLEGE OF MEDICAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (2) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmeditomedine added as a additive to bupivacaine in erector spinae plane block in patients undergoing percutaneous nephrolithotomy under general anaesthesia. |
GROUP-BD 20ml of 0.25% of bupivacaine+ dexmeditomedine 1mcg/kg diluted to 2ml with saline. Under ultrasound guidence using 22-gauge 100mm insulated nerve block needle is used and given only once.after that measures the pain score till 24 hours. |
| Comparator Agent |
fentanyl added as a additive to bupivacaine in erector spinae plane block in patients undergoing percutaneous nephrolithotomy under general anaesthesia. |
GROUP-BF 20ml of 0.25% of bupivacaine+ fentanyl 1mcg/kg diluted to 2ml with saline.Under ultrasound guidence using 22-gauge 100mm insulated nerve block needle is used and given only once.After that measures the pain score till 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1,2 AND 3 PATIENTS |
|
| ExclusionCriteria |
| Details |
1 Presence of contraindication to LA agents
2 Obese patients (BMI->30)
3 Psychiatric disorders
4 Presence of infection at the injection site
5 Major cardiac disease and renal failure
|
|
|
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 |
| We hope to ascertain the better additive among the two by comparing duration of post operative analgesia and minimal adverse effects if any. |
10min 30min 1hour 2hour 4hour 6hour 12hour 24 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Post operative pain score. 2)Total analgesic drug consumption in 24hours. 3)Adverse effects |
10min 30min 1hour 2hour 4hour 6hour 12hour 24 hour. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/11/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study procedure: Ethical committee approval will be taken • Informed consent will be obtained • Preoperative evaluation will be done • Randomly allocated in to 2 groups which will be computer generated • Standard general anaesthesia steps followed and patient will be intubated supine. • Patient will be turn prone, ultrasound guided ESPB will be given using linear probe and 22-guage 100mm insulated nerve block given.Group BD: 20ml of 0.25% of bupivacaine+ dexmeditomedine 1mcg/kg diluted to 2ml with saline GROUP BF: 20ml of 0.25% of bupivacaine+ fentanyl 1mcg/kg diluted to 2ml with saline. Once surgery is done patient pain is assessed by Numerical rating scale (NRS) scoring system of 0-10 at: • 10 mins • 30 mins •1hour •2hours •4hours •6hours•12hours •24 hours. If pain score ≥ 4, then patient is given intravenous Paracetamol 1g iv (up to 3 doses /day). If pain persists after 30 minutes of paracetamol injection, then intravenous Diclofenac will be given (up to 2 doses/day). |