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

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What is this study about?

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.

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 preoperative assessment

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

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Kronoberg Vaxjo Sweden
Region Oestergoetland Linkoping Sweden
Rlqbkx Kwnywq Lzpq Kalmar Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.09.2023

Trial locations

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.

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 ID:
2023-505941-21-00
Protocol code:
01
NCT ID:
NCT06349668
Trial Phase:
Therapeutic confirmatory (Phase III)

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