| CTRI Number |
CTRI/2023/03/051128 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
25/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A prospective study to compare efficacy of fentanyl versus buprenorphine as an adjuvant to local anaesthetic hyperbaric bupivacaine given in spinal anaesthesia in orthopaedic surgeries |
|
Scientific Title of Study
|
A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kallepally Sannidhi |
| Designation |
Junior resident |
| Affiliation |
Department of Anaesthesiology, Kasturba medical college |
| Address |
Department of Anaesthesiology
Kasturba medical college
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9989118184 |
| Fax |
|
| Email |
kallepallysannidhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar H D |
| Designation |
Additional professor |
| Affiliation |
Department of Anaesthesiology, Kasturba medical college |
| Address |
Department of Anaesthesiology
Kasturba medical college
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar H D |
| Designation |
Additional professor |
| Affiliation |
Department of Anaesthesiology, Kasturba medical college |
| Address |
Department of Anaesthesiology
Kasturba medical college
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
arunhd2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Kasturba medical college,
Manipal |
|
|
Primary Sponsor
|
| Name |
Kallepally Sannidhi |
| Address |
Department of Anaesthesiology
Kasturba medical college
MAHE
manipal |
| 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 |
| Kallepally sannidhi |
Kasturba medical college |
Main OT complex
Department of Anaesthesiology
MAHE
Manipal
Udupi
KARNATAKA |
9989118184
Kallepallysannidhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients between 20 – 60 years of age, undergoing elective lower limb orthopaedic surgeries with American society of Anaesthesiologists (ASA) physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with known allergy or hypersensitivity to local anaesthetic drugs
Contraindications to regional or spinal anaesthesia
BMI of less that 18.5 or more than 24.9 kg/m2
Patient not willing to give consent
Emergencies, surgeries lasting >4 hours
Patients in whom assessment of sensory and motor blockade is expected to be impossible/ unreliable |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to establish complete sensory and motor blockade
Time for two segment regression and complete motor recovery |
Post spinal
3 mins
6 mins
9 mins
12 mins
15 mins
18 mins
21 mins
Post surgery
0 mins
30 mins
60 mins
90 mins
120 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of side effects- pruritis and urinary retention |
Immediately in postop |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/04/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: A prospective comparative study of efficacy of fentanyl versus buprenorphine as an additive to intrathecal hyperbaric bupivacaine in orthopaedic surgeries Type of Study: A prospective single centre, observational study Aim: To identify safer /more efficient adjuvant between fentanyl and buprenorphine |