Uterine Leiomyoma
Conditions
Interventions
Study group:At 4 hours after operation, nalbuphine 2 mg was diluted with normal saline to 100 mL for intravenous infusion at a rate of 40–50 drops per minute, administered twice daily for 3 consecutiv
Control group:Postoperatively, ibuprofen 0.4 g was diluted with normal saline to 100 mL for intravenous infusion at a drip rate of 40–50 drops per minute, administered twice daily (Bid) for consecutiv
Sponsors
Obstetrics & Gynecology Hospital of Fudan University ,Yangtze River Delta Integration Demonstration Zone(QingPu)
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in the study. 1. Patients undergoing laparoscopic myomectomy who require postoperative analgesia; 2. ASA physical status I–II; 3. Aged 18–65 years, regardless of gender; 4. Body mass index (BMI): 18.5 kg/m^2 <=BMI <=29 kg/m^2; 5. Leiomyoma type: FIGO types 2, 3, 4, 5, and 6 uterine fibroids.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects with any of the following conditions will be excluded from the trial. 1. Poor compliance and inability to cooperate with the operation; 2. Patients with severe organic diseases, including coronary heart disease, bronchial asthma, severe hypertension, severe hematological dysfunction, significantly abnormal liver and renal function, and obvious electrolyte disorders; 3. History of neurological diseases, chronic pain, drug addiction or alcohol abuse, and long-term use of opioid drugs; 4. Allergy to nalbuphine hydrochloride or its ingredients, or a history of opioid drug allergy; 5. Participation in other clinical drug trials within the recent 4 weeks; 6. Patients with any other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse reactions;Postoperative recovery time;rescue analgesic medication and rescue analgesic dosage;Patient satisfaction score; | — |
Countries
China
Contacts
Public ContactJiang Ting
Obstetrics & Gynecology Hospital of Fudan University ,Yangtze River Delta Integration Demonstration Zone(QingPu)
Outcome results
None listed