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Effect of Esketamine on postoperative rebound pain in patients undergoing unilateral total knee arthroplasty: a single-center, randomized, double-blind, placebo-controlled trial protocol

Effect of Esketamine on postoperative rebound pain in patients undergoing unilateral total knee arthroplasty: a single-center, randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069044
Enrollment
Unknown
Registered
2023-03-06
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Rebound pain

Interventions

Esketamine group:In the Esketamine group, subjects will receive an intravenous infusion of Esketamine. The specification of Esketamine is 50 mg/2 ml. When Esketamine is used, it needs to be diluted. T
Placebo group:In the placebo group, subjects will receive 0.9% normal saline intravenous infusion. The infusion pump mode is constant speed pumping, and the pumping time is from the end of intraspinal

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 18-75; BMI<35kg/? ASA Class I - III; The patient meets the treatment standard of total knee arthroplasty: 1.Knee joint pain is obvious, and the painless walking distance is less than 500 meters; 2. Poor effect after conservative treatment; 3. Imaging findings showed obvious damage of knee joint. Specific diseases include rheumatoid arthritis, osteoarthritis, traumatic arthritis and a few primary or secondary osteochondral necrosis diseases

Exclusion criteria

Exclusion criteria: 1. Hemophilic arthritis, Charcot arthritis; 2. Previous operation history of ipsilateral knee joint; 3. Serious cardio-cerebrovascular diseases, such as hypertension grade III, serious valvular disease, chronic heart failure, serious arrhythmia, ischemic heart disease and stroke patients with obvious symptoms; 4. Serious liver and kidney diseases, such as Child III, creatinine clearance rate lower than 35 mL/min; 5. Any patient with nervous or mental disease; 6. Patients with past or present intracranial hypertension; 7. Allergy to local anesthetics; 8. Patients with infection at the puncture site; 9. Those who refuse to participate and cannot understand the written research information; 10. Long-term use of analgesics (people known or suspected of using opioids daily for 7 consecutive days in a 6-month period=, or long-acting opioids within 3 days and any opioids within 24 hours, known or suspected prior to elective surgery) 11. Glaucomatous patients; 12. hyperthyroidism without treatment or insufficient treatment; 13. Patients with obstructive sleep apnea syndrome (STOP Band score = 5);

Design outcomes

Primary

MeasureTime frame
Incidence of rebound pain within 12 hours after operation in the Esketamine group and the placebo group;

Secondary

MeasureTime frame
Incidence of rebound pain at 24 hours after operation;The first time to enter the pain cycle within 12 hours after operation;Time of first rebound pain within 12 hours after operation;NRS pain score at the time of first rebound pain and modified rebound pain score ;NRS scores at rest and exercise at baseline, 0h after operation, AM on the first day after operation, during physical therapy on the first day after operation, PM on the first day after operation, AM on the second day after operation, and PM on the second day after operation;The cumulative consumption of opioids at 0 h, 12 h, 24 h, and 48 h after the operation;The baseline value before operation and the measured value on the first day after operation were measured by standing-walking timing test;Range of motion of active and passive knee joints at baseline and on the first day after operation;Time to reach discharge standard;Length of stay;QOR-15 recovery quality score at baseline and the first day after operation;Blood glucose and cortisol concentration at baseline and on the first day after operation;Patient satisfaction at discharge;

Countries

China

Contacts

Public ContactYang Zhao

The Affiliated Hospital of Qingdao University

zhaoy1979@qdu.edu.cn+86 18661805080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026