Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Split
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Epidural analgesia
Procedure/SurgeryAfter establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned puncture. The epidural space will be identified at the level of the tenth thoracic intervertebral space using the loss of resistance technique and an 18G Tuohy epidural needle. After placing the epidural catheter, 4 ml of local anesthetic Levobupivacaine 0.25% will be administered into the epidural space. After inducing general anesthesia, an additional 4 ml of Levobupivacaine 0.25% will be administered before the surgical incision. Subjects in the control group will receive an infusion of 0.125% Levobupivacaine for 24 hours after the procedure.
Intrathecal opioid analgesia
Procedure/SurgeryAfter establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned intrathecal puncture. Subsequently, at the selected site, the dura will be punctured using a spinal needle (25G Quincke spinal needle), and 0.3 mg of morphine will be administered to the patient. Following the intervention, the patient will be induced into general anesthesia.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Epidural analgesiaActive comparator 1 intervention
Group B: Intrathecal opioid analgesiaOther 1 intervention
Trial outcomes
Primary outcomes
1
NRS score at 24 hours postoperatively
The primary outcome is the difference in NRS score at 24 hours postoperatively at rest and movement. Numeric rating scale (NRS) will be used, ranging from 0-10, where 0 means no pain and 10 means most severe pain.
Time frame
24 hoursSecondary outcomes
1
Intraoperative opioid consumption
Intraoperative opioid consumption in milligrams.
Time frame
Intraoperatively.2
Numeric rating scale (NRS) score at 1, 3, 6, 48 and 72 hours postoperatively
Numeric rating scale (an 11-point scale where 0 = no pain and 10 = most severe pain) score at rest and movement at 1, 3, 6, 48, and 72 hours postoperatively.
Time frame
72 hours.3
Time to first rescue analgesia postoperatively
Time to first rescue analgesia postoperatively in hours.
Time frame
In the first 72 hours postoperatively.4
Total amount of rescue analgesia during 24 and 72 hours postoperatively
Total amount of rescue analgesia during 24 and 72 hours postoperatively in mg.
Time frame
72 hours.Sponsors and contacts
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Source ClinicalTrials.gov