Benign pelvic gynecological diseases including uterine fibroids, benign ovarian cysts, endometriosis
Conditions
Interventions
Anrekefen Intervention Group:Anrefene 1.0 µg/kg was administered intravenously at 0 h, 8 h and 16 h post-operatively
0 h is defined as within 5 minutes of the end of surgery or admission to the PACU. A margin of error of ±15 minutes is permitted for the timing of administration.
Normal Saline Placebo Control Group:Intravenous injections of an equal volume of 0.9% sodium chloride solution were administered at 0 h, 8 h and 16 h post-operatively
the control group was not a group without analgesia, as all patients received baseline multimodal analgesia and on-demand analgesia via patient-controlled intravenous analgesia (PCIA).
Sponsors
Chaohu Hospital Affiliated to Anhui Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18–65; 2. ASA classification I–III; 3. Undergoing elective gynaecological laparoscopic surgery under general anaesthesia; 4. Expected duration of surgery >= 60 minutes; 5. BMI 18–35 kg/m²; 6. Able to understand and complete the NRS pain scale and the QoR-15 questionnaire prior to surgery; 7. Willing to participate in the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Long-term use of opioid analgesics or regular use of analgesics within two weeks prior to surgery; 2. Presence of chronic pelvic pain, chronic abdominal pain or other chronic pain prior to surgery, with an NRS score of >=4; 3. Presence of nausea, vomiting or marked dizziness within 24 hours prior to surgery; 4. Severe hepatic impairment, severe renal impairment or the need for dialysis; 5. Severe cardiopulmonary disease or an anticipated need for continued mechanical ventilation post-operatively; 6. Known allergy to anrifen, sufentanil, NSAIDs, COX-2 inhibitors, 5-HT3 receptor antagonists or other study-related medications; 7. Pregnancy or breastfeeding; 8. Mental illness, cognitive impairment or inability to complete the questionnaire assessment; 9. Direct transfer to the ICU post-operatively; 10. Any other circumstances deemed by the investigator to render the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total QoR-15 score at 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postoperative nausea and vomiting (PONV) within 24h after surgery;Total sufentanil consumption of PCIA from 0 to 24 hours postoperatively;Total QoR-15 score at 48 hours postoperatively;First PCIA compression time;NRS-AUC for resting pain, 0–24 hours post-surgery;Incidence of post-operative PONV;Use of antiemetics;Length of stay in the PACU;Time of first mobility after getting out of bed;Time of first bowel movement;Postoperative 0–24 h exercise-induced pain NRS-AUC; | — |
Countries
China
Contacts
Public ContactYu Yongbo
Chaohu Hospital Affiliated to Anhui Medical University
Outcome results
None listed