| CTRI Number |
CTRI/2025/10/095851 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Epidural Nefopam or Tramadol: What Works Better for Pain Relief After Lower Abdominal Surgery? |
|
Scientific Title of Study
|
Comparative Study Of Epidural Nefopam And Tramadol For Post-operative Pain Management In Lower Abdominal Surgeries: A Randomised Comparative Clinical 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 Prasanna Vadhanan |
| Designation |
HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No 1, Department of Anaesthesia, Vinayaka Missions Medical College and Hospital, Keezhakasakudymedu, Kottuchery Post, Karaikal, Puducherry-609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mancy ChristabelS |
| Designation |
Junior Resident/ Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No.2, Department of Anaesthesia, Vinayaka Missions Medical College and Hospital,Keezhakasakudymedu, Kottuchery Post, Karaikal, Puducherry- 609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9790552281 |
| Fax |
|
| Email |
mansichristabel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mancy ChristabelS |
| Designation |
Junior Resident/ Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room No.2, Department of Anaesthesia, Vinayaka Missions Medical College and Hospital,Keezhakasakudymedu, Kottuchery Post, Karaikal, Puducherry- 609609
PONDICHERRY
609609
India |
| Phone |
9790552281 |
| Fax |
|
| Email |
mansichristabel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinayak Missions Medical College and Hospital |
| Address |
Vinayaka Missions Medical College and Hospital, Keezhakasakudymedu,Kottuchery Post, Karaikal, Puducherry-609609 |
| 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 Mancy Christabel S |
Vinayaka Missions Medical College and Hospital |
Department of Anaesthesia,Vinayaka Missions Medical College and Hospital,Keezhakasakudymedu, Kottuchery Post, Puducherry- 609609
Karaikal
PONDICHERRY |
9790552281
mansichristabel@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Nefopam |
Patients will receive 8 ml of 0.125 percentage of Bupivacaine containing 5 mg of Nefopam epidurally at the end of surgery |
| Comparator Agent |
Group Tramadol |
Patients will receive 8 ml of 0.125 percentage of Bupivacaine containing 20 mg of Tramadol epidurally at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status I and II
2) Patients scheduled for lower abdominal surgeries
3) Patients capable of providing informed written consent and understanding pain assessment instruction
4) Body Mass Index less than 35 kg per metre square |
|
| ExclusionCriteria |
| Details |
1) Patient refusal
2) Contraindication to neuraxial anaesthesia
3) History of significant cardiovascular, respiratory, hepatic or renal dysfunction
4) Known hypersensitivity to study medications
5) History of chronic pain or regular analgesic medication use
6) Psychiatric disorders or inability to comprehend pain assessment tools
7) Pregnancy or Lactation
8) Body Mass index more than 35 kg per metre square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the analgesic efficacy of epidural nefopam versus tramadol in patients undergoing lower abdominal surgeries using Visual Analog Scale (VAS) pain score. |
1st, 2nd, 4th, 6th, 12th ,24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence and severity of adverse effects associated with epidural nefopam and tramadol |
upto first 24 hours postoperatively |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/10/2025 |
| 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 Applicable |
| 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
|
Summary
This prospective, randomized comparative clinical trial investigates the effectiveness and safety of epidural nefopam versus epidural tramadol for postoperative pain management in adult patients undergoing lower abdominal surgeries. One hundred eligible patients will be randomized into two groups: The primary outcome is postoperative pain intensity measured by Visual Analog Scale (VAS) at rest and during movement over 24 hours.
Secondary outcomes include onset and duration of analgesia, need for rescue analgesics, and incidence of adverse effects such as nausea, vomiting, sedation, hypotension, urinary retention, and respiratory depression. The study aims to determine whether epidural nefopam can provide pain relief comparable to tramadol while reducing opioid-related side effects. Findings are expected to guide clinicians in selecting optimal epidural analgesics for enhanced recovery, improved patient satisfaction, and reduced opioid use in lower abdominal surgery patients. |