NCT06595329RecruitingPhase 1
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 · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 15 Jan 2025
- Primary completion date
- 15 Oct 2025
- Lead sponsor
- University Hospital of Split
- Diseases
- Kidney cancer
- NCT number
- NCT06595329
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 15 Jan 2025 to the primary completion date, 15 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
Lab values
- Patients with renal dysfunction (eGFR \<15 or requirement of renal replacement therapy), liver dysfunction (Child-Pugh class C), and heart failure (NYHA IV).
Other
- Patients who refuse to participate in this study.
- Patients with BMI \> 35 kg/m2 or \< 15 kg/m2.
- Patients with ASA physical status classification ≥ IV.
- Patients with chronic opioid dependence.
- Patients for whom it is impossible to carry out the aforementioned interventions for technical reasons.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univeristy Hospital of Split Coordinator of this site? Confirm its status | Split | Croatia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.