Actively Recruiting
Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial
Led by University Hospital of Split · Updated on 2025-03-10
40
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pain management methods for patients undergoing open radical or partial nephrectomy due to renal cell carcinoma (RCC). The trial compares two approaches: epidural analgesia and intrathecal opioid analgesia. They aim to assess differences in acute postoperative pain, side effects, systemic opioid use, and length of hospital and ICU stays. This is a prospective, randomized controlled clinical trial conducted at a single center. Participants will be randomly assigned to either receive an epidural catheter with continuous levobupivacaine infusion or a single intrathecal dose of 300 mcg morphine before general anesthesia. Both groups will undergo surgery under general anesthesia, with vital signs monitored throughout. The epidural catheter is removed after 24 hours, and pain management continues postoperatively with monitoring for adverse effects. During the first 72 hours after surgery, patients’ pain at rest and during movement will be assessed using a numeric rating scale (NRS). Researchers will record opioid consumption, time to first rescue analgesia, and side effects such as hypotension or nausea. They will also monitor heart rate, blood pressure, gastrointestinal function recovery, and length of ICU and hospital stay. Data collection involves direct measurements, patient records, and questionnaires, with the study expected to last up to one year.
CONDITIONS
Brief 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 renal cell carcinoma (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 body mass index (BMI) greater than 35 kg/m2 or less than 15 kg/m2.
- Patients with renal dysfunction indicated by 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 IV or higher.
- Patients with contraindications to the planned interventions, including allergies to anesthetic drugs used, coagulation disorders, or infection at the injection site.
- Patients with chronic opioid dependence.
- Patients unable to communicate preoperatively due to severe dementia, language barriers, or neuropsychiatric disorders.
- Patients for whom the planned interventions cannot be performed for technical reasons.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and 24 hours postoperatively
Participants undergo open radical or partial nephrectomy surgery and receive either epidural analgesia or intrathecal opioid analgesia before general anesthesia. Pain management and physiological functions are monitored during surgery and for the first 24 hours after surgery.
1 surgery day visit and continuous monitoring during hospital stay
Duration - Up to 72 hours postoperatively
Participants are monitored in the intensive care unit for up to 72 hours after surgery for pain assessment, rescue analgesia needs, adverse effects, gastrointestinal recovery, and other post-surgical outcomes.
Continuous monitoring in ICU for 72 hours
Duration - Up to 1 year
Participants' length of ICU and hospital stay are recorded through study completion, up to approximately one year.
Data collected from patient records
Trial Site Locations
Total: 1 location
1
Univeristy Hospital of Split
Split, Croatia, 21000
Actively Recruiting
Research Team
P
Petra Bajto, MD
L
Lenko Šarić, Asst. Prof.
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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