| CTRI Number |
CTRI/2025/05/086270 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare post operative pain relief in patients undergoing abdominal surgeries |
|
Scientific Title of Study
|
A Comparative Study of Epidural Nalbuphine versus Tramadol as an adjuvant to Levobupivacaine for post operative Analgesia in lower abdominal surgeries in a tertiary care centre - A double blind randomises control 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 |
Varun S |
| Designation |
Postgraduate |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Dept of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences,
Chinna Kolambakkam, Madhurantakam,
Chengalpattu District
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7373166684 |
| Fax |
|
| Email |
varun.sambath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Manohar |
| Designation |
Professor and Head of Department |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Dept of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences,
Chinna Kolambakkam, Madhurantakam,
Chengalpattu District
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8903032609 |
| Fax |
|
| Email |
drmanoth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun S |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Dept of Anaesthesiology, Karpaga Vinayaga Institute of Medical Sciences,
Chinna Kolambakkam, Madhurantakam,
Chengalpattu District
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7373166684 |
| Fax |
|
| Email |
varun.sambath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaga Institute of medical sciences and Research Centre,
GST Road
Madhurantakam,
Chengalpattu. Tamilnadu
8903032609 |
|
|
Primary Sponsor
|
| Name |
VARUN S |
| Address |
Dept of Anaesthesiology, Karpaga vinayaga institute of medical sciences, GST Road Chinna Kolambakkam Chengalpattu Tamilnadu 603308 India Cell: 7373166684 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Varun S |
Karpaga vinayaga Institute of Medical sciences |
OT Complex 1st floor, KIMS Hospital block, Dept of Anaesthesiology GST Road, Chinna Kolambakkam
Kancheepuram
TAMIL NADU |
7373166684
varun.sambath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KARPAGA VINAYAGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients posted for lower abdominal surgeries |
| Patients |
(1) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Levobupivacine Heavy 0.125%
Inj. Nalbuphine 10mg
Inj. Tramadol 50 mg |
The surgical procedure will be thoroughly explained, and informed consent will be obtained.The anesthetic management involved a combined spinal-epidural technique. Local anesthesia will be administered at the L2-L3 intervertebral space using 2% lidocaine. An 18-gauge Touhy epidural needle will be inserted, and the epidural space will be identified using the hanging drop method; an epidural catheter will then be inserted 5 cm into the epidural space and secured.
A test dose of 3 ml of 2% lignocaine with adrenaline (1:200,000) will be injected through the epidural catheter. A subarachnoid block will be performed at the L3-L4 interspace while the patient was in a sitting position, utilizing a 25-gauge Quincke’s spinal needle. After confirming the free flow of clear cerebrospinal fluid, 0.5% bupivacaine will be injected. Both the anesthesiologist who administered the combined spinal-epidural anesthesia and the investigator assessing its outcomes will be blinded to the specific drug used. Epidural will be activated 1 hour before the closure of surgery. Analgesic efficacy will be analysed for 48 hours.
Group A will receive epidural 0.125% levobupivacaine (9ml) along with 10 mg nalbuphine (1ml) to make a total volume of 10 ml.
Group B will received epidural 0.125% levobupivacaine (9ml) and 50mg tramadol (1ml) to make a total volume of 10ml. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age from 18 to 60 years
Both male and females |
|
| ExclusionCriteria |
| Details |
Contraindications to regional anaesthesia
Known allergy to any of the study drugs
Lower segment Caeserean section
Associated hepatic or renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS Score
Ramsay sedation score |
30 min, 1hr, 2hrs 4hrs, 8hrs,12 hrs,24 hrs, 36 hrs and 48 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of analgesia
Duration of analgesia
Hemodynamic changes
Side effects |
30 min, 1hr, 2hrs 4hrs, 8hrs,12 hrs,24 hrs, 36 hrs and 48 hrs after surgery |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varun.sambath@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Postoperative pain is a common and distressing experience for patients undergoing surgery. Effective pain management is crucial for patient comfort, early mobilization, and improved recovery outcomes. While regional anesthesia techniques like epidural and spinal anesthesia provide excellent intraoperative analgesia, postoperative pain often necessitates the use of opioid analgesics. Opioids are effective in managing postoperative pain, but they can have significant side effects such as nausea, vomiting, respiratory depression, and constipation. Therefore, there is a continuous search for safer and more effective analgesics with fewer side effects. This study aims to compare the efficacy and safety of two commonly used opioid analgesics, nalbuphine and tramadol, as adjuvants to bupivacaine for postoperative analgesia in patients undergoing lower abdominal surgeries. Nalbuphine, a mixed agonist-antagonist opioid, has demonstrated analgesic efficacy with a lower incidence of respiratory depression compared to full agonists like morphine. Tramadol, a synthetic opioid with a unique mechanism of action, also provides analgesia with a relatively lower risk of respiratory depression. By comparing the analgesic efficacy, duration of analgesia, and side effect profiles of nalbuphine and tramadol, this study will provide valuable insights into the optimal choice of opioid adjuvant for postoperative pain management in lower abdominal surgeries.
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