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A Comparative Study of Oliceridine and Sufentanil on Postoperative Pain Following Posterior Lumbar Spinal Fusion

A Comparative Study of Oliceridine and Sufentanil on Postoperative Pain Following Posterior Lumbar Spinal Fusion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101994
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Lumber Disc Herniation

Interventions

Oliceridine group A:Postoperative Patient-Controlled Analgesia (PCA) Pump: Oliceridine at a dosage of 0.2 mg per kilogram is mixed with normal saline to make up a total volume of 100 ml.
Oliceridine group B:Postoperative Patient-Controlled Analgesia (PCA) Pump: Oliceridine at a dosage of 0.4 mg per kilogram is mixed with normal saline to make up a total volume of 100 ml.
Sufentanil group C:Postoperative Patient-Controlled Analgesia (PCA) Pump: Sufentanil at a dosage of 3 µg per kilogram is mixed with normal saline to make up a total volume of 100 ml.

Sponsors

Shanghai Yangpu District Central Hospital (Yangpu Hospital Affiliated to Tongji University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Select patients with lumbar intervertebral disc herniation who were admitted to Yangpu Hospital Affiliated to Tongji University from January 2025 to December 2026, and underwent lumbar posterior column fusion surgery and required intravenous patient-controlled analgesia treatment after the surgery. 2. The patients should be aged between 18 and 80 years old, regardless of gender. 3. The patients should be classified as ASA I-III grade. 4. Those who voluntarily participate in this study and sign the informed consent form are eligible.

Exclusion criteria

Exclusion criteria: 1. Received any clinical trial within 28 days before the surgery. 2. Had a history of vestibular nerve disorder, dizziness, or nausea and vomiting within 24 hours before the surgery, or received antiemetic treatment, sedative or analgesic treatment (including opioids and tramadol) within 24 hours before the surgery, or received treatment with drugs that may affect the efficacy of analgesia (including centrally acting a-adrenergic drugs, antiepileptic drugs, neuroleptics, antidepressants, antipsychotics), as well as treatment with corticosteroid drugs. 3. Allergic to or having contraindications to the anesthetics, analgesics, rescue analgesics, and antiemetics used in the study; Suffering from diseases that may confound the effectiveness of oliceridine (such as acute pain without a specific cause, acute breakthrough pain in palliative end - of - life care, pain associated with advanced cancer, or pain in patients undergoing concurrent chemotherapy or biologic therapy for cancer). 4. Suffer from mental or neurological diseases (such as epilepsy, depression, schizophrenia, etc.), gastrointestinal obstruction, chronic obstructive pulmonary disease or cor pulmonale, cardiovascular diseases (heart rate less than 50 beats per minute, blood pressure lower than 90/60 mmHg, or atrioventricular block of degree III or above, QT interval prolongation > 450 ms), etc. 5. Those with a definite history of gastrointestinal ulcers, gastrointestinal perforation or bleeding; Subjects whom the researchers consider to have any other factors that make them unsuitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
Numeric Rating Scale, NRS;Bruggrmann comfort scale, BCS;PCA cumulative press count;PCA pump drug consumption;

Secondary

MeasureTime frame
Complications related to analgesia;TNF-a, IL-6;

Countries

China

Contacts

Public ContactYinglin Wang

Shanghai Yangpu District Central Hospital (Yangpu Hospital Affiliated to Tongji University)

13907553360@163.com+86 189 1616 1593

Outcome results

None listed

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