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A Study on the Efficacy and Safety of the Novel Opioid Nalbuphine for Postoperative Analgesia Following Hip Arthroplasty

A Single-Center, Randomized, Double-Blind, Controlled Clinical Study Evaluating the Efficacy and Safety of Different Doses of Nalbuphine versus Sufentanil for Patient-Controlled Analgesia Following Total Hip Arthroplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123372
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Postoperative Pain Management after Hip Replacement

Interventions

Control (Sufentanil) Group: Patients received Patient-Controlled Intravenous Analgesia (PCIA) : Sufentanil at a dose of 2.5 µg/kg.
Low-Dose Nalbuphine Arm: PCIA protocol.:Nalbuphine 0.5 mg/kg + Sufentanil 1.25 µg/kg
Moderate-Dose Nalbuphine Arm: PCIA protocol.:Nalbuphine 1.0 mg/kg + Sufentanil 1.25 µg/kg
High-Dose Nalbuphine Arm: PCIA protocol.:Nalbuphine 1.5 mg/kg + Sufentanil 1.25 µg/kg

Sponsors

Qingdao Huangdao District People‘s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Aged 18-80 years; 2. Scheduled for elective primary total hip arthroplasty (THA); 3. Signed informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients with psychiatric disorders; 2. Severe hepatic or renal impairment (e.g., eGFR <30 mL/min/1.73 m²); 3. Patients with hypersensitivity to opioids (nabumetone or morphine); 4. Patients with a history of long-term opioid use or substance abuse; 5. Patients unable to cooperate with pain assessment (e.g., due to cognitive impairment or language barriers)

Design outcomes

Primary

MeasureTime frame
Resting VAS scores;

Secondary

MeasureTime frame
SpO2;Time to first ambulation;Length of hospital stay (LOS);Total consumption of patient-controlled intravenous analgesia (PCIA);Patient satisfaction;Resting VAS scores;

Countries

China

Contacts

Public ContactQing Liu

Qingdao Huangdao District People‘s Hospital

liu_qing_good@163.com+86 166 7865 9329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026