| CTRI Number |
CTRI/2026/03/106097 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| 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 drug nalbuphine and fentanyl which is better in patients who underwent abdomen surgery and are in icu post surgery |
|
Scientific Title of Study
|
Effectiveness of analgesia between nalbuphine and fentanyl in postoperative patients who underwent Laparotomy a randomized single blinded controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsh Chutke (self) |
| Designation |
PG Resident |
| Affiliation |
Institute of Medical Sciences and SUM hospital |
| Address |
Department of Anaesthesiogy
First floor , IMS and SUM Hospital, K8 Kalinga Nagar, Bhubaneswar, Odisha, PIN : 751003
Mob no : 9145612301
Email: harsh.chutke.hc@gmail.com
Khordha
ORISSA
751003
India |
| Phone |
9145612301 |
| Fax |
|
| Email |
harsh.chutke.hc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Behera |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences and SUM hospital |
| Address |
SICU , Department of Anaesthesiology , IMS and SUM Hospital, K8 Kalinga Nagar , Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
9032660550 |
| Fax |
|
| Email |
anitabehera@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh P Chutke |
| Designation |
PG Resident |
| Affiliation |
Institute of Medical Sciences and SUM hospital |
| Address |
Institute of Medical Sciences and SUM hospital, K8 Kalinga Nagar, Shampur
ORISSA
751003
India |
| Phone |
9145612301 |
| Fax |
|
| Email |
harsh.chutke.hc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences and SUM hospital, BHUBANESWAR |
|
|
Primary Sponsor
|
| Name |
Dr Harsh P Chutke |
| Address |
Flat 302, ekdanta signature apartment, K3 Kalinga Nagar , Bhubaneswar, Odisha |
| 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 Harsh Chutke |
Surgical ICU , Institute of Medical Sciences and SUM hospital |
First floor , department of Anaesthesiology
K8 Kalinga Nagar , Bhubaneswar
Khordha
ORISSA |
9145612301
harsh.chutke.hc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Fentanyl Infusion will be started 1-2 mcg/kg/hr , IV route in icu post OT , pt is monitored for pain in every 2hr interval for 24 hrs |
| Intervention |
Nalbuphine |
Nalbuphine Infusion will be started 0.1mg/kg/hr , IV route in icu post OT , pt is monitored for pain in every 2hr interval for 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than 18 years
2 Male or Female gender
3 ASA i or ii or iii
4 Patients undergoing elective/emergency laparotomy surgeries surgeries and coming to Surgical ICU for observation or for further management with MV support |
|
| ExclusionCriteria |
| Details |
1 Patient refusal
2 Severe systemic illness , ASA iv
3 Patients on chronic opioid use
4 Intraoperative epidural or regional blocks
5 Allergy or hypersensitivity to drugs
6 Patients require prolonged ventilation ie 24 hrs |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effectiveness of analgesia by seeing time taken to start first rescue analgesia |
0,2,4,6,8,10,12,14,16,18,20,22,24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for extubation after stoppage of sedation |
0,2,4,6,8,10,12,14,16,18,20,22,24 hrs |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomised single blinded study performed in our tertiary care centre will have hundred participants 50 in each group. group N will be given Nalbuphine and group F will be given fentanyl, These groups are made from the patients who underwent exploratory laboratory surgery and are in ICU for further management, we will compare the effectiveness of analgesia by seeing time taken to start first rescue analgesia, and also time taken for extubation after stoppage of sedation. |