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Oxelidine: Safety and efficacy of oliceridine (TRV130), a G-protein-biased ligand of the µ-opioid receptor, for the management of pain after gynecological laparoscopic surgery

Oxelidine: Safety and efficacy of oliceridine (TRV130), a G-protein-biased ligand of the µ-opioid receptor, for the management of pain after gynecological laparoscopic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090797
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-10-16
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Uterine adnexal diseases

Interventions

group A:Stop propofol 10 minutes before the end of the surgery and administer 2mg of oxaliplatin intravenously for pain management. Stop pumping remifentanil at the end of the surgery and connect the
group B:Stop propofol 10 minutes before the end of the surgery and administer 2mg of oxaliplatin intravenously for pain management. Stop pumping remifentanil at the end of the surgery and connect the
group C:Stop propofol 10 minutes before the end of the surgery and administer 2mg of oxaliplatin intravenously for pain management. Stop pumping remifentanil at the end of the surgery and connect the
group D:Stop using propofol 10 minutes before the end of the surgery and administer 0.1ug/kg sufentanil for joint analgesia. Stop pumping remifentanil at the end of the surgery and connect the postope

Sponsors

Qionglai Medical Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Patients undergoing gynecological laparoscopic surgery under general anesthesia ,need postoperative analgesia and overnight hospitalization. (2) Age range: 18 to 60 years old, ASA classification: I to II, BMI: 18 to 28kg/m2

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Within 24 hours prior to surgery, there is a history of vestibular nerve disorder, dizziness, nausea, and vomiting, or treatment with antiemetic therapy, sedation, analgesia (including opioids and tramadol), or drugs that may affect analgesic efficacy (including central alpha adrenergic drugs, antiepileptic drugs, tranquilizers, antidepressants, antipsychotics), as well as corticosteroid therapy. (2) Allergies or contraindications to anesthetics, analgesics, salvage analgesics, and antiemetic drugs used in the study. (3) Long term use of painkillers or physical or mental dependence caused by drug abuse. (4) Diseases that may confuse the effectiveness of oxaliplatin (such as acute pain without a specific cause, acute breakthrough pain in palliative end-of-life care, and pain associated with advanced cancer [somatic, visceral, or neuropathic] or pain caused by concurrent use of chemotherapy or biologics for cancer treatment) (5) Patients with hemodynamic instability, respiratory dysfunction, or sleep apnea syndrome (6) Clinically significant abnormal ECGs, as well as clinically significant abnormal laboratory test values indicating liver function impairment (defined as total bilirubin>2 x upper limit of normal [ULN], aspartate aminotransferase [AST] = 1.5 x ULN, and alanine aminotransferase [ALT] = 1.5 x ULN) or renal function impairment (defined as estimated glomerular filtration rate = 29 mL/min/1.73 m2) (known or obtained during screening). (7) Individuals with a clear history of gastrointestinal ulcers, gastrointestinal perforation, or bleeding. (8) Pregnant or lactating women. (9) Researchers believe that subjects with any other factors that are not suitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;

Secondary

MeasureTime frame
Nausea and vomiting score;The frequency and proportion of remedial analgesia in each group;The incidence of adverse reactions in each group;

Countries

China

Contacts

Public ContactYong-Feng Liu

Qionglai Medical Center Hospital

11308906@qq.com+86 189 9600 8690

Outcome results

None listed

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