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The Impact of Epidural Analgesia versus Intravenous Analgesia on Postoperative Quality of Recovery in Patients Undergoing Minimally Invasive Esophagectomy: A Superiority Randomized Controlled Trial

The Impact of Epidural Analgesia versus Intravenous Analgesia on Postoperative Quality of Recovery in Patients Undergoing Minimally Invasive Esophagectomy: A Superiority Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114434
Enrollment
Unknown
Registered
2025-12-11
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Esophageal malignant tumor

Interventions

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18 - 75 years old; 2.ASA I-III; 3.Scheduled minimally invasive esophagectomy (including minimally invasive Mckeown procedure, combined mediastinoscopy and laparoscopy); 4.The participants were fully aware of and voluntarily participated in this study. They were able to sign the informed consent form and voluntarily follow the procedures of this study.

Exclusion criteria

Exclusion criteria: 1.There are contraindications for epidural puncture: such as severe spinal or thoracic deformities, coagulation disorders, local infections, patients' refusal or inability to cooperate, and tumor bone metastasis, etc. 2.There are contraindications for the use of morphine and local anesthetics. 3.Patients with language communication disorders. 4.Patients with abuse of anesthetic drugs; 5.Severe respiratory diseases, sleep apnea syndrome, severe liver and kidney dysfunction, severe cardiovascular and cerebrovascular diseases (NYHA classification III - IV).

Design outcomes

Primary

MeasureTime frame
QoR-15 of postoperative day 3;

Secondary

MeasureTime frame
QoR-15 of postoperative day 1;Incidence of hypotension (systolic blood pressure <90 mmHg) within 24 hours postoperatively;The total number of remedial analgesic administrations within 3 days after the surgery.;mRNA Changes in Incision Skin at the Beginning and End of Surgery;Incidence of adverse reactions (respiratory depression, nausea and vomiting, dizziness, pruritus);QoR-15 of postoperative day 7;Length of Postoperative Hospital Stay;The most painful areas and their characteristics on postoperative days 1, 2, and 3;The incidence of anastomotic fistula during hospitalization;Rehabilitation quality of EORTC QLQ-C30 3 months after surgery;Changes in Immune Cells and Factors in Blood Before Surgery and on the First Postoperative Day;Time for Removal of Urinary Catheter After Surgery;Time of first flatulence after surgery;Total Hospitalization Costs;Postoperative pain scores at rest and during coughing on days 1, 2, 3, 5, and 7;The incidence of pulmonary complications during hospitalization;Time of first ambulation after surgery;

Countries

China

Contacts

Public ContactFei Liu

West China Hospital of Sichuan University

30333870@qq.com+86 189 8060 5856

Outcome results

None listed

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