Skip to content

Study on the Efficacy and Safety of Tegilide Fumarate Intravenous Analgesia in Alleviating Postoperative Pain After Gynecological Surgery

Study on the Efficacy and Safety of Tegilide Fumarate Intravenous Analgesia in Alleviating Postoperative Pain After Gynecological Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121343
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Postoperative Pain After Gynecological Surgery

Interventions

A:Group A received a loading dose of 1 mg Tegilide followed by a Tegilide PCA pump, with the analgesic pump formulation consisting of 5 mg Tegilide diluted in 200 mL normal saline (0.025 mg/mL), auto-
B:Group B received a loading dose of 1 mg Tegilide followed by a Tegilide PCA pump, with the analgesic pump formulation consisting of 10 mg Tegilide diluted in 200 mL normal saline (0.05 mg/mL), auto-
C:Group C received a loading dose of 1 mg Tegilide followed by a Tegilide PCA pump, with the analgesic pump formulation consisting of 20 mg Tegilide diluted in 200 mL normal saline (0.1 mg/mL), auto-a

Sponsors

Women’s Hospital of Nanjing Medical University, Nanjing Women and Children's Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Our study population consisted of patients aged 18–65 years with ASA classification I or II who were scheduled for elective gynecological surgery, including laparoscopic or open procedures, and planned to receive general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Body weight 35 kg/m²; 2. Pregnancy or lactation status; 3. Severe comorbidities involving the heart, lungs, liver, or kidneys; 4. Current use of opioid or non-opioid analgesics for pain management; 5. Concurrent use of other medications that may affect pain response, such as central adrenergic agents (clonidine/dextromethorphan), antiepileptics, sedatives, antidepressants, or antipsychotics; 6. History of drug addiction or alcohol abuse; 7. Corticosteroid use within 3 months; 8. Inability to complete postoperative follow-up visits or poor compliance with visit schedules; 9. Intraoperative change of surgical approach; 10. History of intubation difficulty or anticipated difficult airway. 11. Additional postoperative exclusion criteria included anesthetic adverse events (e.g., allergic reactions, bronchospasm) and surgical complications such as vascular/neural injury, organ damage, subcutaneous emphysema, or postoperative infection.

Design outcomes

Primary

MeasureTime frame
Sum of differences in resting pain intensity within 24 hours postoperatively (rSPID24);

Secondary

MeasureTime frame
rSPID 6;rSPID 12;rSPID 48;rSPID 12-24;rSPID 24-48;Sum of differences in activity pain intensity within 6 hours postoperatively (aSPID);aSPID 12);aSPID 24;aSPID 48;aSPID 12 -24;aSPID 24 -48;the time of first PCA administration;frequency of analgesic pump compression within 48 hours;Frequency and dosage of rescue analgesics ;opioid analgesic consumption within 48 hours;Percentage of patients with time-related unused rescue analgesics;Incidence of respiratory depression 48 hours postoperatively;Incidence of nausea and vomiting;Incidence of intestinal dysfunction (dyspepsia and first bowel movement time);Headache incidence rate;Incidence of pruritus;Ramsay Sedation Scale;Patient satisfaction with analgesia;Length of hospital stay;Preoperative and postoperative biochemical indicators related to liver and kidney function;

Countries

China

Contacts

Public ContactWang Xian ; Wang Zhaohui

Women’s Hospital of Nanjing Medical University, Nanjing Women and Children's Healthcare Hospital

1240260583@qq.com+86 137 7072 3174

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026