| CTRI Number |
CTRI/2025/02/079972 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of analgesic effect of intrathecal nalbuphine and fentanyl as an adjuvant to 0.75% Ropivacaine in infra umbilical surgeries |
|
Scientific Title of Study
|
A Comparative Study of Analgesic Effect of Intrathecal Nalbuphine and Fentanyl as an Adjuvant to 0.75% Ropivacaine in Infra-Umbilical Surgeries
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Kumari |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Deoghar |
| Address |
Anaesthesia Department,AIIMS Deoghar, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
9473359607 |
| Fax |
|
| Email |
aashisingh2709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Deoghar |
| Address |
Department of Anaesthesia, Aiims deoghar,Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
7063956225 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Kumari |
| Designation |
Junior Resident |
| Affiliation |
Aiims Deoghar |
| Address |
Department of Anaesthesia Aiims deoghar, Devipur
Deoghar
JHARKHAND
814152
India |
| Phone |
9473359607 |
| Fax |
|
| Email |
aashisingh2709@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims Deoghar, Devipur Jharkhand,Pincode -814152 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical ScienceDeoghar |
| Address |
Department of Anaesthesia AIIMS Deoghar, Devipur, Jharkhand Pincode-814152 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Vikash Bansal |
TYPE 4-5 building AIIMS DEOGHAR, DEVIPUR |
|
|
Countries of Recruitment
|
India
United Kingdom |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana Kumari |
AIIMS Deoghar |
Operation Theatre, Department of Anaesthesia Aiims deoghar Devipur, Jharkhand Pincode -814152
Deoghar
JHARKHAND |
9473359607
aashisingh2709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of AIIMS DEOGHAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patient |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl
|
Fentanyl dose- 25 mcg
Route- intrathecal
25 mcg fentanyl+ 3 ml 0.75 % Ropivacaine
|
| Intervention |
Nalbuphine |
Dose of nalbuphine -1mg
Route- intrathecal
1mg Nalbuphine With 0.75 % Ropivacaine 3 ml intrathecally
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1-Elective infra umbilical surgeries
2-BMI-18.5-29.9kg/m2
3-ASA physical status1&2 |
|
| ExclusionCriteria |
| Details |
1-Patient having contraindications to spinal anaesthesia
2-Pregnancy
3-Patient allergic to local anaesthesia
4-Peripheral vascular disease
5- Patient with known or suspected autonomic neuropathy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the analgesic effect of nalbuphine and fentanyl as an adjuvant to 0.75% ropivacaine |
Instant after intrathecal adminstration, then 30 min after adminstration then continue for 6 hr. at a interval of 30 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Less need of repetition of other analgesic with nalbuphine if use as an adjuvant to 0.75% Ropivacaine intrathecally |
After 30 min. Of intrathecal adminstration continue for 6 hr. at an interval of 30 min. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/02/2025 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
RCT double blinded study to compare analgesic effect of intrathecal nalbuphine and fentanyl as an adjuvant to 0.75% Ropivacaine in infra umbilical surgeries compare analgesic effect and see after how much duration repetition of any other analgesic required in which group |