Comparing pain management methods for kidney surgery
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial
This study is testing which pain management method, either an epidural or an intrathecal opioid, works better for people having kidney surgery to help them recover more comfortably.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Split Academic / other |
| Locations | 1 site (Split) |
| Trial ID | NCT06595329 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two pain management techniques, epidural analgesia and intrathecal opioid analgesia, in patients undergoing open radical or partial nephrectomy for renal cancer. It is a prospective, single-center, randomized controlled trial conducted at the University Hospital of Split. The study will monitor various parameters, including acute pain levels, side effects, and the consumption of systemic analgesics during the first 72 hours post-surgery. The goal is to determine which method provides better pain relief and overall recovery outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old scheduled for open radical or partial nephrectomy due to renal cell carcinoma.
Not a fit: Patients with severe comorbidities, contraindications to the interventions, or those unable to communicate preoperatively may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing major kidney surgeries.
How similar studies have performed: Previous studies have shown varying success with similar pain management approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Split
- Univeristy Hospital of Split — Split, Croatia (Recruiting)
Study contacts
- Principal investigator: Svjetlana Došenović, MD Phd — UH Split
- Study coordinator: Petra Bajto, MD
- Email: p.bajto@gmail.com
- Phone: +385955234851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.