Effect of One-Month Oral Oxycodone on Postoperative Pain and Functional Recovery Following Total Knee Arthroplasty: A Randomized Clinical Trial

Evaluation of the effectiveness of oral prescription of Oxycodone in comparison with standard analgesic treatment on postoperative pain and final function after knee replacement surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220413054520N1

Enrollment

190

Registered

2022-05-23

Start date

2022-05-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Knee replacement surgery. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Oral immediate-release oxycodone hydrochloride 5 mg every 12 hours for 4 weeks post-op. Intervention 2: Control group: Matching placebo tablets on same schedule.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of knee osteoarthritis requiring surgical intervention. Undergo primary total knee arthroplasty. Willingness and ability to provide informed consent. Commitment to comply with the study protocol and complete follow-up.

Exclusion criteria

Exclusion criteria: Current use of antidepressants or antiepileptic drugs. History of previous surgery on the affected knee. Patients who were involved in this trial for their previous knee (bilateral TKAs), and/or participation in other clinical trials Body Mass Index (BMI) > 40 or 2.0 mg/dL, liver enzymes > 3 times the upper limit of normal). Active infection or ongoing inflammatory conditions affecting the knee joint. Psychiatric or cognitive conditions impairing the ability to comply with the study protocol. Pregnancy or lactation. Reluctance to cooperate or continue with follow-up.

Design outcomes

Primary

Measure	Time frame
Patient's knee pain. Timepoint: 1, 7, and 30 days post-surgery. Method of measurement: Visual Analogue Scale score.	—

Secondary

Measure	Time frame
Knee function and recovery. Timepoint: 1 month and 6 months post-surgery. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Knee function and recovery. Timepoint: 1 month and 6 months post-surgery. Method of measurement: Oxford Knee Score (OKS).;Sleep Quality. Timepoint: 1 month post-surgery. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).;Satisfaction with the surgical outcome. Timepoint: 6 months post-surgery. Method of measurement: scale from 0 to 10.;Hospital length of stay. Timepoint: During hospitalization. Method of measurement: Calculating the number of days of hospitalization after surgery.	—

Measure

Time frame

Knee function and recovery. Timepoint: 1 month and 6 months post-surgery. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Knee function and recovery. Timepoint: 1 month and 6 months post-surgery. Method of measurement: Oxford Knee Score (OKS).;Sleep Quality. Timepoint: 1 month post-surgery. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).;Satisfaction with the surgical outcome. Timepoint: 6 months post-surgery. Method of measurement: scale from 0 to 10.;Hospital length of stay. Timepoint: During hospitalization. Method of measurement: Calculating the number of days of hospitalization after surgery.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Hadi Kalantar

Tehran University of Medical Sciences

hadikalantar4@gmail+98 21 6119 0000

Outcome results

None listed

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