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CTRI Number  CTRI/2023/07/055550 [Registered on: 24/07/2023] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized Factorial Trial 
Public Title of Study   A clinical trial to assess the effect of combined duloxetine and tapentadol in pain of knee replacement surgery  
Scientific Title of Study
Modification(s)  		 Efficacy and safety of preemptive duloxetine and tramadol combination for the control of postoperative pain in patients undergoing unilateral total knee arthroplasty: A randomized, double-blind 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 Debashish Hota 
Designation  Professor anf HoD  
Affiliation  AIIMS Bhubaneswar 
Address  Department of Pharmacology 115, Academic Block AIIMS bhubaneswar-751019

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DR Debashish Hota 
Designation  Professor HOD  
Affiliation  AIIMS Bhubaneswar 
Address  Department of Pharmacology

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  pharm_debasish@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Debasish Hota 
Designation  Professor HOD  
Affiliation  AIIMS Bhubaneswar 
Address  Academic Block Department of Pharmacology

Khordha
ORISSA
751019
India 
Phone  9438884190  
Fax    
Email  www.subham917@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BHUBANESWAR 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Patrapada, Sijua, pin 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujit Kumar Tripathy  AIIMS Bhubaneswar  Room no. 17 Department of Orthopaedics AIIMS, Bhubaneswar-751019
Khordha
ORISSA 		 9438884155

ortho_sujit@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of duloxetine & tapentadol tablets  Single dose of Tab. duloxetine (30 mg) + tab tapentadol (100 mg) 2 hours before surgery 
Comparator Agent  Placebo capsule  Matched placebo capsule 2 hours before surgery 
Comparator Agent  Tab duloxetine 30 mg  Single dose of Tab. duloxetine (30 mg) 2 hours before surgery  
Comparator Agent  Tab tapentadol 100 mg  Single dose of Tab.tapentadol (100 mg) 2 hours before surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients both male and females undergoing unilateral total knee arthroplasty surgery.
2. Patients who can provide informed consent
3. Age group between 18-75 years
 
 
ExclusionCriteria 
Details  1. Patients with chronic diseases including asthma, COPD, or any other respiratory disease.
2. Persistent nausea and vomiting at the time of randomization
3. History of seizure
4. Subjects treated with monoamine oxidase inhibitors, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, gabapentinoids.
5. Patient with known neurological/ neuropsychiatric disorders.
6. Drug or alcohol abuse history
7. Opioid tolerance or opioid dependence.
8. Known history of opioid allergy or pregabalin allergy.
9. Renal disease (creatinine >1.5mg/dl)
10. Liver disease (total bilirubin ≥ 1.5mg/dl, AST or ALT ≥ 3 times ULN))
11. Pregnancy and lactating women.
12. Cardiovascular insufficiency.
13. Patient with potential serotonin syndrome.
14. Patient with a history of constipation and prone to paralytic ileus.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean difference in VAS score ( 0 to 100 mm) post operatively in 4 groups  0, 24 hour post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate pain score in visual analog scale (VAS) at 0, 6 & 12 hours postoperatively in patients undergoing TKA


 		 0 , 6, 12 hour post operatively 
2. To evaluate the efficacy of pre-emptive analgesia independent of time points

 		 0 ,6 ,12 ,24 hour post operatively 
3. Reduction of VAS to 3 or less at the end of 12 hours from 6 hours without nausea & vomiting

 		 6 , 12 hour post operatively 
4. Comparing differences in TOTPAR (none, mild, moderate & severe) scale at 0, 6,12, 24 hours post-operatively in both the groups

 		 0 ,6 ,12 ,24 hour 
5. Time to first request for rescue analgesia postoperatively

 		 within 24 hour post operatively 
6. Mean difference in total analgesic consumption in both the groups postoperatively.

 		 within 24 hour 
7. Estimation of plasma hs-CRP at baseline & 6 hours postoperatively in all the groups by ELISA.
 		 0 ,6 hour post operatively 
8. Monitoring treatment-emergent adverse events (TEAE) on a four-point verbal scale in both the groups including post-operative nausea vomiting (PONV).  24 hour post operative 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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 4 
Date of First Enrollment (India)   01/08/2023 
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)
Modification(s)  		 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 - NO
Brief Summary  

Despite the availability of multiple analgesic treatment modalities, postoperative pain management is sometimes neglected & under-managed. Also, post-operative high-dose opioids have significant multiple side effects like constipation, paralytic ileus, nausea, vomiting, sedation etc. Prolonged periods of opioid usage for pain management can lead to opioid dependence as well. On the other hand, postoperative long-term NSAID use can lead to renal and hepatic impairment. Thus, there is a dire need for alternative therapeutic options in the management of post-operative pain. The present study has been planned to evaluate the effectiveness of Duloxetine combined with Tapentadol as pre-emptive analgesia in TKA by comparing the pain score, cumulative dosage of opioids, high-sensitivity C-reactive protein (hs-CRP) level, and adverse effects after TKA. We hypothesize that the effectiveness of duloxetine combined with Tapentadol as TKA pre-emptive analgesia would lead to satisfactory clinical outcomes. The primary objective of the present study is to evaluate the effectiveness of Duloxetine combined with Tapentadol as TKA pre-emptive analgesia by compared the pain score, cumulative dosage of opioids, high-sensitivity C-reactive protein (hs-CRP) level, and adverse effects after TKA. 

 
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