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Comparison of the Analgesic Efficacy and Safety of Oliceridine Versus Sufentanil for Patient-Controlled Intravenous Analgesia After Posterior Lumbar Fusion

Comparison of the Analgesic Efficacy and Safety of Oliceridine Versus Sufentanil for Patient-Controlled Intravenous Analgesia After Posterior Lumbar Fusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127799
Enrollment
Unknown
Registered
2026-07-07
Start date
2026-07-07
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Postoperative pain after posterior lumbar fusion surgery

Interventions

Oliceridine Group:Patient-Controlled Intravenous Analgesia with Oliceridine
Sufentanil Group:Patient-Controlled Intravenous Analgesia with Sufentanil and Ondansetron

Sponsors

The Second Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–65 years, any gender. 2.Diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbarspondylolisthesis,scheduled for elective single-level or two-level posterior lumbar fusion. 3.American Society of Anesthesiologists (ASA) physical status classification I–III. 4.No history of chronic pain before surgery; no long-term use of opioids, non-steroidal anti-inflammatory drugs (NSAIDs), or sedative-hypnotics. 5.Clear consciousness, able to understand and cooperate with VAS (Visual Analog Scale) scoring, Ramsay sedation scale assessment, and questionnaire surveys. 6.Voluntarily signed written informed consent and willingness to complete the entire study.

Exclusion criteria

Exclusion criteria: 1.Allergy to oliceridine, sufentanil, or other components of the analgesic pump (e.g., normal saline, antiemetics). 2.Preoperative significant respiratory insufficiency (FEV1 2 times the upper limit of normal, serum creatinine >133 µmol/L). 3.Presence of coagulation disorders, history of peptic ulcer, or recent bleeding tendency. 4.History of drug abuse, psychiatric disorders, or cognitive impairment. 5.Pregnant or lactating women. 6.Anticipated operative time exceeding 4 hours, intraoperative blood loss >800 mL, or requiring postoperative admission to the intensive care unit (ICU). 7.Concomitantacute pain at other sites, or development of severe postoperative complications (e.g., infection, loosening of internal fixation) that affect pain assessment. 8.Refusal to use intravenous patient-controlled analgesia (PCA) pump, or inability to cooperate with follow-up observations.

Design outcomes

Primary

MeasureTime frame
VAS pain score at rest at 24 hours postoperatively;

Secondary

MeasureTime frame
Postoperative Quality of Recovery-15 (QoR-15) Scores at 24 and 48 Hours;Incidence of Postoperative Respiratory Depression;ncidence of Postoperative Nausea and Vomiting (PONV);Number of Patient-Controlled Analgesia (PCA) Pump Demands;Time to First Ambulation and Length of Hospital Stay;Postoperative Analgesia Satisfaction;Postoperative Resting Visual Analogue Scale (VAS) Scores at Multiple Time Points;

Countries

China

Contacts

Public ContactXin Zhao

The Second Qilu Hospital of Shandong University

lujnzx@sohu.com+86 531 85875951

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026