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The Application of Oliceridine for Postoperative Analgesia in Patients Undergoing Spinal Surgery: A Multicenter, Randomized, , Double-blind,Controlled trial

The Application of Oliceridine for Postoperative Analgesia in Patients Undergoing Spinal Surgery: A Multicenter, Randomized, , Double-blind,Controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084733
Enrollment
Unknown
Registered
2024-05-23
Start date
2024-05-24
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Spinal Surgery

Interventions

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. For patients undergoing elective lumbar decompression and fusion surgery; 2. Age 18-65 years, gender unlimited; 3. ASA grade I-lll; 4. After fully explaining the content of the clinical trial participants should voluntarily join and sign the informed consent;

Exclusion criteria

Exclusion criteria: 1. Patients with a known allergy to opioids or opioid intolerance, and those who have been on long-term oral opioids. 2. Patients with serious comorbidities such as impaired liver or kidney function, pulmonary dysfunction, or heart failure. 3. Patients with uncontrolled diabetes or hypertension, and those with suspected gastrointestinal obstruction. 4. Patients with abnormal electrocardiogram findings, such as QT interval prolongation >450ms. 5. Patients with a BMI = 30kg/m2, obstructive sleep apnea syndrome, or a STOP-Bang score =3. 6. Patients with a history of severe postoperative nausea and vomiting. 7. Patients with a history of mental illnesses like schizophrenia, preoperative delirium, or communication barriers. 8. Patients deemed lacking the capacity to give informed consent. 9. Other patients deemed unsuitable for participation in the study by the attending physician or clinical supervisor.

Design outcomes

Primary

MeasureTime frame
Incidence of moderate to severe pain within 48 hours after surgery;

Secondary

MeasureTime frame
NRS scores for the patient during rest and activity;The number of PCA pressing times of the patient;Incidence of postoperative adverse reactions in patients;Quality of patient recovery after surgery;Patient satisfaction after surgery;Postoperative sedation of patients;Opioid dosage;Preoperative baseline and intraoperative and postoperative variables;Remedial analgesic dosage;

Countries

China

Contacts

Public ContactYe Zhang

The Second Affliated Hospital of Anhui Medical University

zhangye_hassan@sina.com+86 139 6676 8081

Outcome results

None listed

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