| CTRI Number |
CTRI/2025/03/082275 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| 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
|
A scientific experiment comparing two drugs Fentanyl and Buprenorphine when used along with the drug Hyperbaric Levobupivacaine in patients coming for cesarean section. |
|
Scientific Title of Study
|
The Efficacy of Fentanyl versus Buprenorphine as an adjuvant to intrathecal hyperbaric levobupivacaine in Cesarean section:A prospective Randomised comparative clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandakishor A Mane |
| Designation |
Postgraduate student |
| Affiliation |
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
2nd floor Department of Anaesthesiology, New Stone Building, Mysore Medical College and Research Institute, Irwin road, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
8073071417 |
| Fax |
|
| Email |
nandkishoremane319@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR B C Vijayalakshmi |
| Designation |
PROFESSOR |
| Affiliation |
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
2nd floor Department Of Anaesthesiology, New Stone Building, Mysore Medical College And Research Institute, Irwin Road, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
9886239622 |
| Fax |
|
| Email |
vijayanagaraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nandakishor A Mane |
| Designation |
Postgraduate student |
| Affiliation |
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
2nd Floor Department Of Anaesthesiology, New Stone Building, Mysore Medical College And Research Institute, Irwin Road, Mysore.
Mysore
KARNATAKA
570001
India |
| Phone |
8073071417 |
| Fax |
|
| Email |
nandkishoremane319@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cheluvamba Hospital, Irwin road, Devaraj Mohalla, Yadavgiri, Mysore, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Mysore Medical College |
| Address |
Mysore Medical College and Research Institute, Irwin road, Mysore, Karnataka 570001 |
| Type of Sponsor |
Government 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 Nandakishor A Mane |
Cheluvamba hospital |
1st Floor Department of OBG, Irwin road, Devaraja mohalla, Yadavgiri, Mysore, Karnataka 570001
Mysore
KARNATAKA |
8073071417
nandkishoremane319@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
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 |
Buprenorphine |
Under aseptic precautions lumbar puncture done at L3-L4 level using 25G Quincke spinal needle, after getting free flow of CSF 1.8ml injection hyperbaric levobupivacaine 0.5% heavy + 60mcg (0.2ml) of injection Buprenorphine given intrathecally.Total 2ml |
| Intervention |
Fentanyl |
Under aseptic precautions lumbar puncture done at L3-L4 level using 25G Quincke spinal needle, after getting free flow of CSF 1.8ml injection hyperbaric levobupivacaine 0.5% heavy + 20mcg (0.4ml) of injection Fentanyl given intrathecally. Total 2.2ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All patients of age group 18 to 35 years, belonging to ASA grade 1 and 2 ,with height ranging from 150-180cms.,and weight ranging from 50-90kgs. coming for cesarean delivery. |
|
| ExclusionCriteria |
| Details |
.Patients with spinal deformity
.Gestational age less than 36 weeks
.Patients with medical and obstetric complication
.Patients allergic to study drugs
.Patients with local skin infections
.Patients with impaired renal and liver function tests
.Patients with coagulation disorder
,Patients not willing to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
.Onset and duration of sensory blockade
.Maximum sensory blockade and time taken for it
.Time for two segment sensory regression
.Total duration of analgesia
.Onset and duration of motor blockade
.Quality of motor blockade and time taken for maximum motor blockade. |
.Time of onset of sensory block at T10
.Time of attaining maximum sensory blockade
.Time for two segment sensory regression
.Total duration of analgesia
.Time taken for maximum motor blockade. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Hemodynamic parameters like HR,SBP,DBP,MAP
.Neonatal assessment using APGAR scoring
.Adverse effects |
24hrs |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="6"
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
|
This study is a prospective randomized comparative clinical study comparing the efficacy of Fentanyl and Buprenorphine when used as an adjuvant to 0.5% Hyperbaric levobupivacaine in patients coming for cesarean delivery where the effect of Fentanyl and Buprenorphine on sensory block ,motor block ,duration of analgesia is compared in Cheluvamba hospital. |