| CTRI Number |
CTRI/2022/10/046720 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
20/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of Nalbuphine and fentanyl as spinal additives |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF INTRATHECAL NALBUPHINE VERSUS FENTANYL AS ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN PARTURIENTS UNDERGOING ELECTIVE LSCS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR THEJASVI B R |
| Designation |
POST GRADUATE MEDICAL STUDENT |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, K R MARKET, BANGALORE KARNATAKA 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9886254822 |
| Fax |
|
| Email |
tejasvi2694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DAYANANDA V P |
| Designation |
PROFESSOR |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, K R MARKET, BANGALORE KARNATAKA 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
vpd921@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DAYANANDA V P |
| Designation |
PROFESSOR |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, K R MARKET, BANGALORE KARNATAKA 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
vpd921@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, K R MARKET, 560002, BANGALORE |
|
|
Primary Sponsor
|
| Name |
DR THEJASVI B R |
| 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 DAYANANDA V P |
DEPARTMENT OF ANAESTHESIOLOGY, BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, KR MARKET 560002, BANGALORE |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR THEJASVI B R |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
DEPARTMENT OF ANAESTHESIA, BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, KR MARKET, 560002, BANGALORE
Bangalore
KARNATAKA |
9886254822
tejasvi2694@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: O748||Other complications of anesthesiaduring labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NALBUPHINE |
NALBUPHINE IS GIVEN AS ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN PARTURIENTS UNDERGOING ELECTIVE LSCS FOR A PERIOD OF 6 MONTHS
|
| Comparator Agent |
TNTRATHECAL FENTANYL |
5MCG-25MCG USED AS ADJUVANT IN SPINAL ANAESTHESIA IN PARTURIENTS UNDERGOING ELECTIVE LSCS SHOWN TO INCREASE DURATION OF POST OPERATIVE EFFECTIVE ANALGESIA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.PARTURIENTS WILLING TO GIVE WRITTEN INFORMED CONSENT
2.SUBARACHNOID BLOCK BELONGING TO ASA I AND II
3.WOMEN WITH SINGLETON PREGNANCY CONFIRMED ON ANTENATAL ULTRASOUND
4.PREGNANT WOMEN WITH HEIGHT RANGING BETWEEN 150-180CM AND HEIGHT 50-90KG |
|
| ExclusionCriteria |
| Details |
1.PATIENTS UNDERGOING EMERGENCY LSCS
2.PATIENTS WITH MEDICAL AND OBSTRETRIC COMPLICATIONS LIKE ANAEMIA, HEART DISEASE, PRE-ECLAMPSIA AND ECLAMPSIA, GESTATIONAL DIABETES ,SHOCK,SEPTICEMIA,BLEEDING DIATHESIS,LOCAL INFECTION
3.ANY HYPERSENSITIVITY REACTION TO STUDY DRUGS
4.SUBJECTS HAVING ABSOLUTE COMPLICATIONS FOR SPINAL ANAESTHESIA
5.CONGENITAL ANOMALIES DIAGNOSED ON ANTENATAL ULTRASOUND
6.FAILURE OF SPINAL BLOCKADE
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.ONSET OF SENSORY BLOCKAD
2.ONSET OF MOTOR BLOCKADE
3.TOTAL DURATION OF ANALGESIA |
5mins
6mins
4hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MAXIMUM LEVEL OF SENSORY BLOCK AND TIME TAKEN
MAXIMUM MOTOR BLOCKADE AND TIME TAKEN FOR THE SAME
ANALGESIC REQUIREMENT FOR FIRST 24HRS POSTOPERATIVELY |
5min
6min
3hrs
24hrs |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/10/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
INTRATHECAL FENTANYL IS BEING USED AS SPINAL ADJUVANT AND HAS SHOWN TO PROVIDE EFFECTIVE POST OPERATIVE ANALGESIA, IN THIS STUDY WE COMPARE THE EFFECT OF INTRATHECAL NALBUPHINE AS SPINAL ADJUVANT.
|