Clinical trial · Interventional
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
| Renal Cancer | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epidural analgesia | Procedure | — | UNRESOLVED |
| Intrathecal opioid analgesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Epidural analgesia
- description
- An epidural catheter will be placed before induction to the anesthesia. A local anesthetic Levobupivacaine 0.25% (Levobupivakain Kabi ®, Fresenius Kabi Norge AS, Svinesundsveien, Norway, 5 mg/ml) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia.
- interventionNames
- Procedure: Epidural analgesia
- type
- OTHER
- label
- Intrathecal opioid analgesia
- description
- Patients in the Intervention group will receive a single dose of 300 mcg of morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) intrathecally before induction to general anesthesia.
- interventionNames
- Procedure: Intrathecal opioid analgesia
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
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