Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy

NCT06595329 | Recruiting Phase 1

• 1 other identifier: 2181-147/01/06/LJ.Z.-23-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pain; Renal Cancer; Surgical Procedure, Unspecified

Keywords

Pain management; open nephrectomy; renal cell carcinoma

Outcome Measures

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.

  24 hours

Secondary Outcomes (9)

• Intraoperative opioid consumption

  Intraoperatively.

• Numeric rating scale (NRS) score at 1, 3, 6, 48 and 72 hours postoperatively

  72 hours.

• Time to first rescue analgesia postoperatively

  In the first 72 hours postoperatively.

• Total amount of rescue analgesia during 24 and 72 hours postoperatively

  72 hours.

• Incidence of adverse effects

  72 hours.

Study Arms (2)

Epidural analgesia

ACTIVE COMPARATOR

An epidural catheter will be placed before induction to the anesthesia. A local anesthetic Levobupivacaine 0.25% (Levobupivakain Kabi ®, Fresenius Kabi Norge AS, Svinesundsveien, Norway, 5 mg/ml) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia.

Procedure: Epidural analgesia

Intrathecal opioid analgesia

OTHER

Patients in the Intervention group will receive a single dose of 300 mcg of morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg/ml) intrathecally before induction to general anesthesia.

Procedure: Intrathecal opioid analgesia

Interventions

Epidural analgesia PROCEDURE

After 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.

Epidural analgesia

Intrathecal opioid analgesia PROCEDURE

After 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.

Also known as: Intrathecal morphine analgesia

Intrathecal opioid analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

Univeristy Hospital of Split

Split, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Pain; Kidney Neoplasms; Agnosia; Carcinoma, Renal Cell

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Svjetlana Došenović, MD Phd

  UH Split

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Bajto, MD

CONTACT

+385955234851; p.bajto@gmail.com

Lenko Šarić, Asst. Prof.

CONTACT

lenko.saric@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly divided into two groups in a 1:1 ratio. Randomization will be performed using a computer program. A research coordinator will be designated to distribute and preserve randomization results. A person designated for data analysis will be blinded for intervention performed in each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Prospective, single-center, randomized controlled trial. The study will take place in the University Hospital of Split, Departments of Anesthesiology, Reanimatology and Intensive Care Medicine, and the Department of Urology. Patients undergoing open radical or partial nephrectomy for renal cancer will be randomized to one of the two groups: Epidural analgesia (Control) or intrathecal opioid (Intervention) group. Physiologic functions (blood pressure, heart rate, peripheral oxygen saturation) will be monitored during and after the surgery. Postoperatively, pain scores at rest as well as during movement will be recorded. A total dose of intraoperative opioids, time to first rescue analgesic, and total dose of rescue analgesics as well as adverse effects during the first 72 hours postoperatively will be recorded. These parameters will be compared between the two groups.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: January 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

CR (1)