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Epidural versus Intravenous Analgesia with Dexmedetomidine Combined with Esketamine for Postoperative Pain After Open Gynecological Oncology Surgery: A Prospective, Randomized, Non-Inferiority Trial

Epidural versus Intravenous Analgesia with Dexmedetomidine Combined with Esketamine for Postoperative Pain After Open Gynecological Oncology Surgery: A Prospective, Randomized, Non-Inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113658
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Postoperative pain after gynecological tumor surgery

Interventions

Intravenous Analgesia Pump Group:150 ug Sufentanil + 150 mg Flurbiprofen Ester + 30 mg Esketamine + 75 ug Dexmedetomidine + normal saline, diluted to a total volume of 150 ml. Patient-Controlled Intra
Epidural Analgesia Pump Group:125 ug Sufentanil + 300 mg Ropivacaine + normal saline, diluted to a total volume of 250 ml. Patient-Controlled Epidural Analgesia (PCEA) with a background infusion rate

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 2.ASA Class I-II 3. Gynecological malignant tumor surgery will be opened at an appropriate time 4.BMI < 35

Exclusion criteria

Exclusion criteria: 1.Inability to provide informed consent, unable to communicate. 2.Contraindications to epidural anesthesia. 3.Glaucoma. 4.Resting heart rate 160/100 mmHg. 6.History of psychiatric disorder. 7.History of cardiovascular events such as heart failure, myocardial infarction, aortic dissection, or aneurysm. 8.Second or third-degree atrioventricular block.

Design outcomes

Primary

MeasureTime frame
AUC of VAS scores over 24 hours;

Secondary

MeasureTime frame
VAS score of patients in PACU;Patient's medication use in the PACU;Nausea and Vomiting VAS score at 28 hours after surgery.;RASS score at 28 hours after surgery.;Postoperative Day 2 (POD2) Pain VAS;Postoperative Day 2 (POD2) Nausea/Vomiting VAS;Postoperative Day 2 (POD2) RASS scores.;Postoperative Day 3 Pain VAS score;Postoperative Day 3 QoR-15 score;Postoperative Day 2 Richards-Campbell Sleep Questionnaire (RCSQ) score;Time to first flatus;

Countries

China

Contacts

Public ContactJun Zhang

Fudan University Shanghai Cancer Center

snapzhang@aliyun.com+86 138 1715 3025

Outcome results

None listed

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