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

Recruiting now · Phase 1

Conditions studied: Pain, Renal Cancer, Surgical Procedure, Unspecified

In brief

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.

Key facts

Study ID: NCT06595329
Run by: University Hospital of Split
People needed: 40
Starts: 2025-01-15
Expected to finish: 2025-12-31
Last updated by the study team: 2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients over the age of 18, scheduled for an open radical or partial nephrectomy due to RCC.
American Society of Anesthesiologists (ASA) physical status classification I-III.

You may not qualify if…

Patients who refuse to participate in this study.
Patients with BMI > 35 kg/m2 or < 15 kg/m2.
Patients with renal dysfunction (eGFR <15 or requirement of renal replacement therapy), liver dysfunction (Child-Pugh class C), and heart failure (NYHA IV).
Patients with ASA physical status classification ≥ IV.
Patients with contraindication for the interventions planned for in this study (allergies to anesthetic drugs used in this study, coagulation disorders, and infection at the injection site).
Patients with chronic opioid dependence.
Patients unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
Patients for whom it is impossible to carry out the aforementioned interventions for technical reasons.

Where it is running

Univeristy Hospital of Split — Split, Croatia (enrolling)

Full record on ClinicalTrials.gov

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