CTRI/2023/07/055550
Recruiting
Phase 4
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 - NI
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: - Health Condition 2: M171- Unilateral primary osteoarthritisof knee
- Sponsor
- AIIMS Bhubaneswar
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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))
Outcomes
Primary Outcomes
Not specified
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