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

RecruitingPhase 1Ages 18 Years - anyAllUniversity Hospital of Split
NCT06595329 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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.
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What it tests

  • Epidural analgesia
  • Intrathecal opioid analgesia
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Where

1 site
Univeristy Hospital of Split
Split, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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