Actively Recruiting
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
Led by University Hospital of Split · Updated on 2025-03-10
40
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Patients who refuse to participate in this study.
- Patients with BMI greater than 35 kg/m2 or less than 15 kg/m2.
- Patients with renal dysfunction (eGFR less than 15 or requiring renal replacement therapy).
- Patients with liver dysfunction classified as Child-Pugh class C.
- Patients with heart failure classified as NYHA IV.
- Patients with ASA physical status classification of IV or higher.
- Patients with allergies to anesthetic drugs used in this study, coagulation disorders, or 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 the planned interventions cannot be performed for technical reasons.
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Trial Site Locations
Total: 1 location
1
Univeristy Hospital of Split
Split, Croatia, 21000
Actively Recruiting
Research Team
P
Petra Bajto, MD
CONTACT
L
Lenko Šarić, Asst. Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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