NCT06595329 Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
| NCT ID | NCT06595329 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital of Split |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2025-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-01-15 with a primary completion date of 2025-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Svjetlana Došenović, MD Phd
PRINCIPAL INVESTIGATOR
UH Split
Frequently Asked Questions
Who can join the NCT06595329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06595329 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06595329 currently recruiting?
Yes, NCT06595329 is actively recruiting participants. Contact the research team at p.bajto@gmail.com for enrollment information.
Where is the NCT06595329 trial being conducted?
This trial is being conducted at Split, Croatia.
Who is sponsoring the NCT06595329 clinical trial?
NCT06595329 is sponsored by University Hospital of Split. The principal investigator is Svjetlana Došenović, MD Phd at UH Split. The trial plans to enroll 40 participants.