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Study on Spinal Morphine, Intravenous Lidocaine, and Bupivacaine for Patients Undergoing Robot-Assisted Surgery for Kidney or Ureter Conditions

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on improving recovery after surgery for patients undergoing robot-assisted upper urinary tract surgery, which is a type of surgery involving the kidneys or ureters. The study is particularly interested in conditions such as renal cancer, ureter cancer, benign kidney tumors, kidney stones, and kidney reflux. The trial will explore the effects of different pain management strategies during and after surgery.

Participants in the study will receive one of the following treatments: spinal morphine, which is derived from the opium poppy and administered directly into the spinal fluid, or intravenous lidocaine, a common local anesthetic given through a vein. Additionally, some patients will receive a combination of bupivacaine, another local anesthetic, and adrenaline, which helps prolong the effects of the anesthetic. The purpose of the study is to determine if these treatments can enhance recovery after surgery, as measured by a patient-centered outcome scale called "Quality of Recovery 15."

The study will involve a random assignment of treatments to participants, and it will be conducted without the participants knowing which treatment they are receiving. The trial will monitor recovery progress, including pain levels and overall well-being, at various points after surgery. The goal is to find the most effective pain management strategy to improve the recovery experience for patients undergoing this type of surgery.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The patient is scheduled for elective robotic-assisted upper urinary tract surgery at a participating hospital.

    The patient provides oral and written informed consent after receiving detailed information about the study.

  2. Step 2

    Preoperative assessment

    The patient's initial health status is evaluated using the Quality of Recovery 15 (QoR-15) score, which measures recovery quality.

  3. Step 3

    Surgery preparation

    The patient is prepared for surgery, which involves general anesthesia and may include spinal analgesia with bupivacaine and morphine to improve recovery.

  4. Step 4

    Surgery

    The patient undergoes robotic-assisted laparoscopic upper urinary tract surgery.

    The time from arrival in the operating room to the start of surgery and from the end of surgery until leaving the operating room is recorded.

  5. Step 5

    Postoperative care

    The patient's recovery is monitored in the post-anesthesia care unit (PACU).

    Pain levels are assessed using the Numeric Rating Scale (NRS) at rest and during motion.

    The length of stay in the PACU and the amount of opioids administered are recorded.

  6. Step 6

    Postoperative day 1

    The patient's QoR-15 score is evaluated to assess recovery quality.

    Pain levels and any postoperative nausea and vomiting (PONV) requiring treatment are monitored.

  7. Step 7

    Postoperative days 2-3

    The patient's QoR-15 score is reassessed.

    Pain levels and the amount of opioids administered are recorded.

    The patient is encouraged to be out of bed and to monitor the first postoperative day of passing gases and stool.

  8. Step 8

    Postoperative follow-up

    The patient is monitored for any complications until postoperative day 30.

    The requirement for opioids after discharge and any incidence of respiratory depression are assessed.

  9. Step 9

    Study completion

    The study is estimated to end by December 31, 2025, with all data collected and analyzed to determine the effectiveness of the treatments.

Who can join the trial?

4 criteria

  • The patient is scheduled for a planned robotic-assisted surgery on the upper part of the urinary tract. This means the surgery is not an emergency and involves using robotic tools to help with the operation.
  • The patient has given both spoken and written permission to participate in the study after receiving information about it. This is called giving informed consent.
  • The patient can be of any gender, as both male and female participants are allowed.
  • The patient falls within the age range of adults and older adults.

Who cannot join the trial?

3 criteria

  • Having a **cancer** or **tumor** in the **kidney** or **ureter**. The **ureter** is the tube that carries urine from the kidney to the bladder.
  • Having **kidney stones**. These are hard deposits made of minerals and salts that form inside the kidneys.
  • Having **renal reflux**. This is a condition where urine flows backward from the bladder to the kidneys.
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Investigated drugs

  • Bupivacaine

    is a medication used to numb a specific area of the body to relieve pain during and after surgery. In this trial, it is administered as part of spinal analgesia to help improve recovery after robotic-assisted laparoscopic upper urinary tract surgery.

  • Morphine

    is a strong pain reliever used to manage severe pain. In this study, it is given intrathecally, which means it is injected into the space around the spinal cord, to help reduce pain and improve recovery after surgery.

  • Lidocaine

    is a local anesthetic used to numb tissue in a specific area. In this trial, it is administered intravenously, meaning it is injected into a vein, to help manage pain and improve recovery following surgery.

What is already known about the treatment

  • Morphine

    Morphine is typically administered through injection, either intrathecally (into the spinal canal) or intravenously. It is a well-established medication in medical literature, primarily used for pain management. In this clinical trial, it is being studied for its potential to improve recovery after robotic-assisted upper urinary tract surgery. Morphine works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain. It is classified as an opioid analgesic.

  • Lidocaine

    Lidocaine is commonly administered intravenously and is widely recognized in medical literature for its use as a local anesthetic and antiarrhythmic agent. In this trial, it is being evaluated for its effects on postoperative recovery following robotic-assisted upper urinary tract surgery. Lidocaine functions by blocking sodium channels, which inhibits nerve impulse conduction, leading to reduced pain sensation. It is classified as a local anesthetic.

Investigated diseases

  • Renal Malignancy

    This is a type of cancer that originates in the kidneys. It often begins in the cells lining the small tubes within the kidneys. As the disease progresses, it can grow and potentially spread to other parts of the body. Symptoms may include blood in the urine, a lump in the abdomen, or unexplained weight loss. The progression can vary, with some tumors growing slowly while others may be more aggressive.

  • Ureter Malignancy

    This cancer affects the ureters, which are the tubes that carry urine from the kidneys to the bladder. It typically starts in the cells lining the ureter and can cause symptoms like blood in the urine and back pain. As it progresses, it may obstruct urine flow and spread to nearby tissues or organs. The disease can vary in its rate of progression and severity.

  • Renal Benign Tumor

    These are non-cancerous growths in the kidney. They do not spread to other parts of the body and are often found incidentally during imaging tests for other conditions. While they are generally not life-threatening, they can sometimes cause symptoms if they grow large enough to affect kidney function or cause pain. The growth rate of these tumors can vary, and they may remain stable for long periods.

  • Ureter Benign Tumor

    These are non-cancerous growths in the ureter. They are less common than malignant tumors and typically do not spread to other areas. Symptoms may include blood in the urine or urinary obstruction. The progression is usually slow, and they may not require treatment unless they cause significant symptoms.

  • Nephrolithiasis

    Commonly known as kidney stones, this condition involves the formation of hard mineral deposits in the kidneys. These stones can vary in size and may cause severe pain when passing through the urinary tract. Symptoms include sharp pain in the back or side, blood in the urine, and frequent urination. The condition can recur, and stones may form again over time.

  • Renal Reflux

    Also known as vesicoureteral reflux, this condition occurs when urine flows backward from the bladder into the ureters and kidneys. It can lead to urinary tract infections and kidney damage over time. Symptoms may include frequent urinary tract infections, bedwetting, and high blood pressure. The severity of the condition can vary, with some cases resolving on their own while others may persist.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505941-21-00Protocol code01Estimated enrolment220 patientsSponsorRegion Oestergoetland

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