Clinical study on the efficacy and safety of tezanidine preemptive analgesia in total knee arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500104341

Enrollment

Unknown

Registered

2025-06-16

Start date

2025-06-16

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Knee osteoarthritis

Interventions

Control group:Placebo

study group:Take 2mg of tezanidine hydrochloride tablets orally one hour before the operatio

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 80 who received total knee arthroplasty (TKA) due to primary unilateral knee osteoarthritis.

Exclusion criteria

Exclusion criteria: (1) Patients who have undergone TKA surgery for other reasons, such as rheumatoid arthritis and hemophilia arthritis; (2) BMI>40 kg/m^2; (3) Abnormal liver function; Defined as: Defined as 1.5 times the upper limit of the reference range for alanine aminotransferase and aspartate aminotransferase levels; (4) Allergy to tezzanidine hydrochloride; (5) Opioid dependence: Defined as the use of opioid drugs or local anesthetics equivalent to more than 100 milligrams of morphine per week before surgery to control pain for more than 3 months; (6) Neuromuscular dysfunction affecting the lower extremities, such as Parkinson's disease, myasthenia gravis, etc. (7) Knee flexion deformity >= 30° or varus deformity >= 30°; (8) ASA classification exceeds Grade III.

Design outcomes

Primary

Measure	Time frame
Postoperative hospital stay (0-24 hours; The dosage of morphine hydrochloride for remedial analgesia within 24 hours - after discharge.;	—

Secondary

Measure	Time frame
The time interval (hours) of the first use of morphine for remedial analgesia after the operation;Postoperative knee pain;Evaluation of knee joint function during hospitalization: including the range of motion of the knee joint and the walking distance;Postoperative hospital stay (in days);Intraoperative stress-related outcomes, including the consumption of intraoperative opioids and/or inhaled anesthetics and the frequency of intraoperative hypertensive attacks;Postoperative stress-related results included the rate of morphine remedial analgesia in the PACU and the levels of serum cortisol and ACTH in the morning of the first postoperative day;Postoperative blood inflammatory indicators;Complications during postoperative hospital stay;	—

Measure

Time frame

The time interval (hours) of the first use of morphine for remedial analgesia after the operation;Postoperative knee pain;Evaluation of knee joint function during hospitalization: including the range of motion of the knee joint and the walking distance;Postoperative hospital stay (in days);Intraoperative stress-related outcomes, including the consumption of intraoperative opioids and/or inhaled anesthetics and the frequency of intraoperative hypertensive attacks;Postoperative stress-related results included the rate of morphine remedial analgesia in the PACU and the levels of serum cortisol and ACTH in the morning of the first postoperative day;Postoperative blood inflammatory indicators;Complications during postoperative hospital stay;

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Countries

China

Contacts

Public ContactZongke Zhou

West China Hospital of Sichuan University

zhouzongke@scu.edu.cn+86 189 8060 1028

Outcome results

None listed

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