Clinical Trial

Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy

Recruiting Phase 1
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Record status
This record was last updated March 10, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma (RCC). Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay, open surgery is still often performed. Open nephrectomy causes significant acute postoperative pain, and it can also lead to the development of chronic postoperative pain. Pain management is important for the overall recovery of patients undergoing major surgery such as open nephrectomy and it is a part of the enhanced recovery after surgery (ERAS) program. In this prospective randomized clinical study, we plan to compare two different approaches to pain management regarding the level of acute pain (first 72 hours), side effects, systemic analgesics consumption, and hospital stay. Our hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy. We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-10.
Status change: Not Yet Recruiting → Recruiting 2025-03-05
Trial Details
NCT Number NCT06595329
Lead Sponsor University Hospital of Split
Conditions Pain, Renal Cancer, Surgical Procedure, Unspecified
Enrollment 40 participants
Start Date 2025-01-15
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-10