A clinical trial to assess the effect of combined duloxetine and tapentadol in pain of knee replacement surgery

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 - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055550

Enrollment

125

Registered

2023-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: preemptive duloxetine & tapentadol combination: 1.Group-1: Tapentadol (100 mg) plus duloxetine (30 mg) 2.Group-2: Duloxetine (30 mg) alone 3.Group-3: Tapentadol (100 mg) alone 4.Group-4

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Mean difference in VAS score ( 0 to 100 mm) post operatively in 4 groupsTimepoint: 0, 24 hour post operatively	—

Secondary

Measure	Time frame
1. To evaluate pain score in visual analog scale (VAS) at 0, 6 & 12 hours postoperatively in patients undergoing TKA Timepoint: 0 , 6, 12 hour post operatively;2. To evaluate the efficacy of pre-emptive analgesia independent of time points Timepoint: 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 Timepoint: 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 Timepoint: 0 ,6 ,12 ,24 hour;5. Time to first request for rescue analgesia postoperatively Timepoint: within 24 hour post operatively;6. Mean difference in total analgesic consumption in both the groups postoperatively. Timepoint: within 24 hour;7. Estimation of plasma hs-CRP at baseline & 6 hours postoperatively in all the groups by ELISA. Timepoint: 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).Timepoint: 24 hour post operative	—

Measure

Time frame

1. To evaluate pain score in visual analog scale (VAS) at 0, 6 & 12 hours postoperatively in patients undergoing TKA Timepoint: 0 , 6, 12 hour post operatively;2. To evaluate the efficacy of pre-emptive analgesia independent of time points Timepoint: 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 Timepoint: 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 Timepoint: 0 ,6 ,12 ,24 hour;5. Time to first request for rescue analgesia postoperatively Timepoint: within 24 hour post operatively;6. Mean difference in total analgesic consumption in both the groups postoperatively. Timepoint: within 24 hour;7. Estimation of plasma hs-CRP at baseline & 6 hours postoperatively in all the groups by ELISA. Timepoint: 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).Timepoint: 24 hour post operative

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Countries

India

Contacts

Public ContactDr Debasish Hota

AIIMS Bhubaneswar

pharm_debasish@aiimsbhubaneswar.edu.in9438884190

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026