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The Effect of Oliceridine on Postoperative Pain and Gastrointestinal Function Recovery in Gynecologic Laparoscopic Surgery: A Double-Blind Randomized Controlled Trial

The Effect of Oliceridine on Postoperative Pain and Gastrointestinal Function Recovery in Gynecologic Laparoscopic Surgery: A Double-Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110159
Enrollment
Unknown
Registered
2025-10-09
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Gynecologic Laparoscopic Surgery

Interventions

Group O:After intraoperative specimen removal, connect to an intravenous analgesic pump. Group O: Administer an intravenous loading dose of 0.04 mg/kg Oliceridine
Analgesic pump formulation: 0.35 mg/kg Oliceridine diluted with normal saline to 100 ml, infusion rate 2 ml/h, bolus dose 0.5 ml.
Group S:After intraoperative specimen removal, connect to an intravenous analgesic pump. Administer an intravenous loading dose of sufentanil 0.2 µg/kg. Analgesic pump formulation: 2 µg/kg sufentanil

Sponsors

Anqing Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for elective gynecologic laparoscopic surgery; 2.ASA physical status I-III; 3.Age 18-65 years; 4.BMI 18-32 kg/m^2, and body weight >40 kg; 5.Meets ethical standards, voluntarily participates in the trial, and provides signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Severe cardiac, pulmonary, hepatic, or renal dysfunction; 2.History of psychiatric disorders, long-term use of psychotropic drugs, chronic analgesic medication use, or history of alcoholism; 3.Patients with severe infections; 4.Language or hearing impairment, or cerebral dysfunction such as stroke, unable to communicate; 5.Preoperative PaO2 <60 mmHg or SpO2 <92%; 6.Participation in another drug clinical trial within the past 30 days; 7.Patient or family refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of moderate to severe acute pain (NRS score >3 or requiring rescue analgesia) within 24 hours postoperatively.;Time to first flatus postoperatively;

Secondary

MeasureTime frame
Postoperative dynamic pain NRS scores: NRS scores at rest and during coughing immediately, 0.5 h, 2 h, 6 h, and 24 h after laryngeal mask airway removal;Mean postoperative dynamic pain NRS scores: Area under the curve/24h of NRS scores at rest and during coughing immediately, 0.5 h, 2 h, 6 h, and 24 h after laryngeal mask removal;Postoperative 24h PCIA attempts;Postoperative rescue analgesia: Time to first rescue analgesia, number of rescue analgesia events within 24h, total dosage of rescue analgesics;Incidence of chronic pain: Incidence of chronic pain at 1 month and 3 months postoperatively;Time to first defecation postoperatively: The time interval from the end of surgery to the first defecation;Time to first ambulation postoperatively: The time from the end of surgery to the first ambulation; Postoperative GI function score (I-FEED): 5 components (oral intake, nausea, vomiting, abdominal distension symptoms, and symptom duration);

Countries

China

Contacts

Public ContactDuan Jinjuan

Anqing Municipal Hospital

djjayd223@163.com+86 189 0966 5698

Outcome results

None listed

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