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CTRI Number  CTRI/2025/07/090700 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between the two pain reliving drugs (tramadol and nalbuphine) when added to a Local anaesthetic drug (Ropivacaine) in patients with knee replacement surgery  
Scientific Title of Study   A comparative study of Epidural Nalbuphine vs Tramadol as an adjuvant to 0.2% Ropivaciane for post operative pain relief in unilateral total knee replacement 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  Dr Harshita jain 
Designation  DNB Resident 
Affiliation  Rukmani Birla hospital 
Address  Rukmani Birla hospital Ck birla hospital Triveni nagar Shanti nagar gopalpura bypass road jaipur 302018

Jaipur
RAJASTHAN
302018
India 
Phone  9700000736  
Fax    
Email  jainharshita702@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Baid 
Designation  Additional Director , department of Anesthesia  
Affiliation  Rukmani Birla hospital  
Address  Rukmani Birla hospita Ck birla hospital Triveni nagar Shanti nagar gopalpura bypass road jaipur 302018

Jaipur
RAJASTHAN
302018
India 
Phone  9828119109  
Fax    
Email  drruchibaid@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ruchi Baid 
Designation  Additional Director , department of Anesthesia  
Affiliation  Rukmani Birla hospital  
Address  Rukmani Birla hospita Ck birla hospital Triveni nagar Shanti nagar gopalpura bypass road jaipur 302018

Jaipur
RAJASTHAN
302018
India 
Phone  9828119109  
Fax    
Email  drruchibaid@gmail.com  
 
Source of Monetary or Material Support  
Rukmani birla hospital,Gopalpura Bypass Rd, Near Triveni Flyover, Shanthi Nagar, Gopal Pura Mode, Jaipur, Rajasthan, India 302018 
 
Primary Sponsor  
Name  Rukmani Birla hospital  
Address  Anaesthesia HOD office, 1st floor, Rukmani birla hospital, Jaipur, Rajasthan, India- 302018 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Baid  Rukmani Birla Hospital  Anaesthesia HOD office, 1st floor, Rukmani birla hospital
Jaipur
RAJASTHAN 		 9828119109

ruchi.baid@ckbirlahospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rukmani Birla hospital ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nalbuphine with ropivacaine  0.2% Ropivacaine with 0.2mg/ml nalbuphine as an adjuvant for pain relief in post-operative period at 30 min, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour and 24 hour 
Comparator Agent  Tramadol with Ropivacaine  0.2% Ropivacaine with 2mg/ml Tramadol as an adjuvant for pain relief in post-operative period at 30 min, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour and 24 hour  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Giving the consent
ASA grade 1 and 2
Age groups 45-70 years 
 
ExclusionCriteria 
Details  ASA 3/4
Refusal of consent
Bleeding diathesis
Contraindication to epidural anaesthesia
Pregnancy and lactating mother 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain assessment   30 mins 1 hr 2 hr 4 hr 6 hr 12 hr 24 hr  
 
Secondary Outcome  
Outcome  TimePoints 
PONV , patient satisfaction   30 mins 1 hr 2 hr 4 hr 6 hr 12 hr 24 hr  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   21/07/2025 
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)  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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jainharshita702@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is a randomized control double blind study , single centre trial comparing the efficacy of Nalbuphine 0.2mg/ml and Tramadol 2mg/ml as an adjuvant to 0.2% Ropivacaine epidurally for post-op analgesia in unilateral total knee replacement surgery. Total sample size is 50 patients divided in two equal groups. The primary outcome measures will be difference in VAS score between groups at 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours. The secondary outcomes will be patient satisfaction, post-op nausea and vomiting and requirement of breakthrough analgesia.
 
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