Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
Launched by UNIVERSITY HOSPITAL OF SPLIT · Sep 10, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different methods of managing pain for patients undergoing open nephrectomy, which is surgery to remove a kidney due to cancer. The trial compares epidural analgesia (pain relief through an injection in the back) and intrathecal opioid analgesia (pain relief through an injection directly into the spinal fluid) to see which method is more effective at reducing pain in the first 72 hours after surgery, as well as which has fewer side effects and requires less use of other pain medications.
To be eligible for this trial, participants must be adults over 18 years old who are scheduled for this type of surgery and are generally healthy (classified as ASA I-III). Those with certain health conditions, severe obesity or underweight, or issues that prevent them from participating (such as allergies to the medications used) will not be included. Participants can expect to receive one of the two pain management techniques during their surgery and will be monitored for pain levels and any side effects afterward. This study aims to improve recovery experiences for patients undergoing major surgery.
Gender
ALL
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.
About University Hospital Of Split
The University Hospital of Split, a leading medical institution in Croatia, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent academic hospital affiliated with the University of Split, it combines cutting-edge medical practices with rigorous scientific inquiry. The institution specializes in a wide range of medical fields, fostering collaborations among healthcare professionals, researchers, and educators. With a commitment to improving patient outcomes and contributing to the global medical community, the University Hospital of Split plays a pivotal role in the development of new therapies and treatment protocols through its robust clinical trial programs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Split, , Croatia
Patients applied
Trial Officials
Svjetlana Došenović, MD Phd
Principal Investigator
UH Split
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported