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Effectiveness and Safety of Oliceridine Fumarate for Postoperative Pain Management in Open Abdominal Surgery: A Randomized Controlled Trial

Effectiveness and safety of oliceridine fumarate for postoperative analgesia in patients undergoing open abdominal surgery: a prospective, randomized, double-blind, pragmatic study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117288
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Postoperative pain

Interventions

Experimental Group (Oliceridine Fumarate):In the experimental group, blinded investigators will administer a loading dose of oliceridine fumarate (5 mL, 0.20 mg/mL) prior to abdominal closure (before
Control Group (Sufentanil):In the control group, blinded investigators will administer sufentanil (5 mL, 2 µg/mL) prior to abdominal closure (before peritoneal suturing). The PCIA device is loaded wit

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged 18–75, ASA classification I–III; scheduled to undergo open gastrointestinal, hepatobiliary, or pancreatic surgery; participants have provided informed consent.

Exclusion criteria

Exclusion criteria: Patients with severe cardiovascular diseases (e.g., grade III hypertension, unstable angina, severe valvular heart disease, severe arrhythmias, severe major vascular diseases); those with allergies to or tolerance of opioids; severe hepatic or renal dysfunction (Child-Pugh grade C, CKD stage 4); uncontrolled respiratory diseases (such as frequent acute exacerbations of asthma, acute exacerbation of chronic obstructive pulmonary disease, active upper respiratory tract infections, and pulmonary infections); body mass index 30 kg/m²; and those who have received immunosuppressive therapy within the past month.

Design outcomes

Primary

MeasureTime frame
Time-weighted VAS score during activity from 0 to 48 hours postoperatively;

Secondary

MeasureTime frame
Cumulative postoperative opioid consumption;Time to first patient-controlled analgesia (PCA) bolus;Quality of Recovery-15 (QoR-15) score;Patient satisfaction with analgesia;Time to gastrointestinal function recovery;Time to first ambulation;Postoperative length of hospital stay;Extra rescue analgesic dosage;

Countries

China

Contacts

Public ContactYouzhuang Zhu

The Affiliated Hospital of Qingdao University

youzhuang_zhu@qdu.edu.cn+86 158 6301 3837

Outcome results

None listed

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