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Clinical study on the application of Oxyline for patient-controlled intravenous analgesia after laparoscopic myomectomy under the ERAS concept

Clinical study on the application of Oxyline for patient-controlled intravenous analgesia after laparoscopic myomectomy under the ERAS concept

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114262
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-20
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Uterine fibroids

Interventions

Oseri Ding Group:30 minutes before the surgery, a loading dose of 1.5mg of oxilast was slowly injected intravenously
after the surgery, a PCIA pump was connected. The PCIA pump contained 0.5mg/kg of oxilast, 24mg of ondansetron, and 0.9% normal saline diluted to 100ml. The parameters of the PCIA pump were a backgrou
Sufentanil group:30 minutes before the surgery, a loading dose of sufentanil 7.5 ug was slowly injected intravenously
after the surgery, a PCIA pump was connected. The PCIA pump contained 2.5 ug/kg of sufentanil, 24 mg of ondansetron, and 0.9% normal saline diluted to 100 ml. The parameters of the PCIA pump were a ba

Sponsors

The General Hospital of the Northern Theater Command of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old, ASA classification is grade I to II, female, 18.5 kg/m^2 <=BMI < 30 kg/m^2; 2.The diagnosis of uterine fibroids was clear before the operation, and the patient is scheduled to undergo laparoscopic uterine fibroid resection under general anesthesia.

Exclusion criteria

Exclusion criteria: 1.During pregnancy or lactation; 2. BMI >=30 kg/m^2 or < 18.5 kg/m^2; 3.Complicated with pelvic inflammatory disease, polycystic ovary syndrome and other types of gynecological disorders; 4.Motion sickness and with a clear history of severe nausea and vomiting; 5.Having primary mental disorders; 6.Preoperative coexisting with important organ diseases, such as heart, lung, liver and kidney dysfunction; Chronic systemic disease history; 7.History of cerebrovascular disease; 8. History of drug abuse; 9.Recent use of analgesic drugs such as opioids; 10.Allergic to any of the trial drugs; 11. Long-term use of opioid drugs; 12. Unable to understand the Numerical Rating Scale (NRS) and Visual Analogue Scale (VAS)

Design outcomes

Primary

MeasureTime frame
The total incidence of nausea and vomiting 48 hours after the operation;

Secondary

MeasureTime frame
Duration of the surgery;The 24-hour resting NRS score after the operation;The resting NRS score 48 hours after the operation;The NRS score induced by activity 24 hours after the operation;The NRS score induced by activity 48 hours after the operation;The number of times the pain-relieving pump was pressed within 48 hours after the operation;Cumulative usage of opioid drugs;Size of uterine fibroids;Perioperative vital signs;

Countries

China

Contacts

Public ContactCao Huijuan

The General Hospital of the Northern Theater Command of the People's Liberation Army of China

caohuijuan1212@sina.com+86 133 0988 0882

Outcome results

None listed

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