Using Oliceridine for Pain Relief After Surgery
Enhanced Postoperative Analgesia and Accelerated Recovery With Oliceridine: A Study on G-Protein Biased μ-Opioid Agonist
NA · Tongji Hospital · NCT06409689
This study is testing different doses of a new pain medication called oliceridine to see how well it helps people manage pain after upper abdominal surgery compared to morphine.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06409689 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the optimal dosage of oliceridine for managing postoperative pain in patients undergoing upper abdominal laparoscopic surgery. It involves 80 elective patients who will be randomly assigned to receive different doses of oliceridine or morphine for pain management. The study will assess various outcomes, including pain relief, recovery speed, and potential side effects, while also exploring the molecular mechanisms behind oliceridine's effects through microbiomics and metabolomics. This innovative approach seeks to enhance postoperative recovery and broaden the understanding of oliceridine's clinical applications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 scheduled for elective upper abdominal laparoscopic surgery with ASA grades I-II.
Not a fit: Patients with a BMI outside the range of 19-30, preoperative opioid use, or significant heart, liver, or kidney conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that enhance recovery and reduce side effects for postoperative patients.
How similar studies have performed: While this study employs a novel combination of omics approaches, previous studies have shown promise in using oliceridine for pain management, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA grades 1-2 2. Age \> 18 years and \< 70 years 3. Laparoscopic upper abdominal surgery under general anesthesia is planned, and the operation time is not more than 4 hours 4. Voluntarily receive postoperative controlled intravenous analgesia 5. Subjects understand and can cooperate with this study 6. Subjects can provide and sign written informed consent prior to conducting investigation-related screening procedures Exclusion Criteria: 1. BMI\>30 kg/m2 or \< 19 kg/m2 2. Patients with preoperative use of opioids, acute and chronic pain or hyperalgesia 3. Patients with coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease 4. More severe hepatic and renal insufficiency 5. A history of mental illness or alcoholism 6. A history of alcohol or drug abuse 7. Combined with cranial pressure, intraocular pressure or glaucoma 8. Poorly controlled or untreated hypertension before surgery 9. Preeclampsia or eclampsia 10. Untreated and undertreated hyperthyroidism 11. Combined with autoimmune disease 12. Unable to use the numerical rating scale 13. History of chronic cough 14. Surgery is expected to take more than 4 hours Patients enrolled in other clinical trials within 3 months
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Hui Xu
- Email: huixu@tjh.tjmu.edu.cn
- Phone: +8613971001596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Analgesia