A clinical trial to assess the effect of combined duloxetine and tapentadol in pain of knee replacement surgery
- Conditions
- Health Condition 1: - Health Condition 2: M171- Unilateral primary osteoarthritisof knee
- Registration Number
- CTRI/2023/07/055550
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference in VAS score ( 0 to 100 mm) post operatively in 4 groupsTimepoint: 0, 24 hour post operatively
- Secondary Outcome Measures
Name Time Method