| CTRI Number |
CTRI/2025/11/097177 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [Pain relief] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Two Pain Medicines given with a Numbing Drug Through a Tube in the Back to Control Pain After Lower Umbilical Surgery |
|
Scientific Title of Study
|
Efficacy of Nalbuphine versus Fentanyl as Epidural Adjuvants to Bupivacaine for Postoperative Analgesia in Infraumbilical
Surgeries: A Comparative 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 |
Dr. R. Brindha |
| Designation |
Professor and HOD - Department of Anaesthesiology |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Brindha |
| Designation |
Professor and HOD Department of Anaestheiology |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Salem
TAMIL NADU
636308
India |
| Phone |
9443247021 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aupama M |
| Designation |
Post Graduate - Department of Anaestheiology |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Salem
TAMIL NADU
636308
India |
| Phone |
8754028970 |
| Fax |
|
| Email |
anu.mohankumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College & Hospital |
| Address |
Chinna Seeragapadi, Salem – 636 308, Tamil Nadu India |
| 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 M Anupama |
Vinayaka Missions Kirupananda Variyar Medical College and hospitals Salem |
Room number 15 Department of Anaesthesiology Vinayaka Missions kirupananda variyar medical college and hospitals
Salem
TAMIL NADU |
8754028970
anu.mohankumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
for surgical procedures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Single shot Fentanyl 100mcg will be given along with 0.125% Bupivacaine diluted to 10 mL in normal saline via epidural catheter, postoperatively when sensory level drops to the umbilicus level |
| Intervention |
Nalbuphine |
Single-shot Nalbuphine 10mg will be given along with 0.125% Bupivacaine diluted to 10 mL in normal saline via epidural catheter, postoperatively when sensory level drops to the umbilicus level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Physical Status 1 and 2
2. Patients undergoing elective infraumbilical surgeries under combined spinal-epidural
anaesthesia
3. Patients willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients on opioids, tricyclic antidepressants, or alpha-2 agonists
2. Patients with coagulation defects and patients on anticoagulants
3. Patients with neuromuscular disorders
4. Patients with disease and deformities of spinal cord
5. Patients allergic to local anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of postoperative analgesia, defined as the time from epidural drug
administration to the first request for rescue analgesia |
0 min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain scores at rest & movement using the Visual Analog Scale (VAS) at predefined
time intervals |
From 0 min of administering drug & 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug |
| Incidence of side effects & derangement in haemodynamic parameters |
From 0 min of administering drug & 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr after administering drug |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2025 |
| 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 aims to compare the efficacy and safety of nalbuphine and fentanyl as epidural adjuvants to 0.125 percent bupivacaine for postoperative analgesia in patients undergoing infraumbilical surgeries. Inadequate pain control after surgery can delay recovery and increase complications therefore optimizing epidural analgesia is crucial. Fentanyl a commonly used opioid offers effective pain relief but may cause side effects such as respiratory depression and nausea. Nalbuphine a kappa agonist and partial mu antagonist provides comparable analgesia with fewer side effects. Sixty adult patients ASA I and II scheduled for elective infraumbilical surgeries under combined spinal epidural anaesthesia will be randomly assigned to receive either nalbuphine 10 mg or fentanyl 100 mcg with 0.125 percent bupivacaine via the epidural route. Postoperative parameters including duration of analgesia pain scores using the Visual Analog Scale haemodynamic stability and side effects will be monitored. The expected outcome is that nalbuphine will produce longer lasting analgesia lower pain scores and fewer opioid related adverse effects compared to fentanyl. |