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Efficacy of Oliceridine and sufentanil in patient-controlled analgesia after Knee unicompartmental arthroplasty

A Study of Oliceridine in the Optimal Management of Pain After Knee Unicompartmental Arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096012
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Knee unicompartmental arthroplasty

Interventions

Ocelidine group:In-pump drug formula: Oliceridine 0.3mg/kg + granisetron hydrochloride 6mg, diluted to 100ml with 0.9% sodium chloride injection
The pump speed is set to 2ml/h, the automatic control locking is 0.5ml, and the locking time is 15min.
Sufentanil group:Sufentanil 1.5µg/kg + granisetron hydrochloride 6mg, diluted to 100ml with 0.9% sodium chloride injection. The pump speed is set to 2ml/h, the automatic control locking is 0.5ml, and

Sponsors

Suzhou Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with knee osteoarthritis aged 65~80 years old who electively plan to undergo unicompartmental knee arthroplasty (UKA); (2) American Society of Anesthesiologists (ASA) grade I.~II.; (3) Those who are conscious and able to cooperate; (4) Those with normal coagulation function; (5) The preoperative VAS score of the patient > 4 points; (6) Patients and their families sign the informed consent form

Exclusion criteria

Exclusion criteria: (1) Contraindications to femoral nerve block: the patient has severe coagulation dysfunction; Infection at the site of block; The preoperative patient is too anxious and refuses to accept the nerve block operation, etc.; (2) Those with mental, verbal or hearing impairments; (3) Frequent use of opioids, history of alcoholism and drug abuse; (4) Patients with severe heart, liver, lung, brain and other organ dysfunction before surgery; (5) The patient has other diseases that may cause severe chronic pain before surgery; (6) History of allergy to local anesthetics; (7) Patients with a preoperative VAS score of < 4.

Design outcomes

Primary

MeasureTime frame
The visual analogy VAS (VAS) scores of pain are recorded in the two groups 4h (T1), 12h (T2), 24h (T3) and 48h (T4) after surgery ;

Secondary

MeasureTime frame
The knee society score system (KSS) scores are measured in the two groups before and 24 hours and 48 hours after surgery;The incidence of rescue analgesia at 48 hours after surgery in the two groups was measured;Heart rate (HR), mean arterial pressure (MAP), respiratory frequency (RF), and the amount of opioids used within 72 hours after surgery were recorded in the two groups at the time of admission (T0), 4 hours (T1), 12 hours (T2), 24 hours (T3) and 48 hours (T4).;

Countries

China

Contacts

Public ContactFen Yang

Suzhou Municipal Hospital

86906200@qq.com+86 512 6236 5368

Outcome results

None listed

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