Ongoing Clinical Trials for Congenital Ureteric Anomaly
This article provides information about ongoing clinical trials for congenital ureteric anomaly and related conditions affecting the upper urinary tract. Currently, there is 1 clinical trial investigating pain management strategies to improve recovery after robot-assisted surgery for kidney and ureter conditions.
Clinical trial locations
Study on Spinal Morphine, Intravenous Lidocaine, and Bupivacaine for Patients Undergoing Robot-Assisted Surgery for Kidney or Ureter Conditions
This trial is focused on improving recovery for patients who need robot-assisted surgery on their upper urinary tract, which includes the kidneys and ureters. The study is investigating different pain management approaches to help patients recover more comfortably and quickly after surgery.
Main inclusion criteria:
- Patients scheduled for planned robot-assisted surgery on the upper urinary tract
- Ability to provide both written and spoken informed consent
- Adult patients of any gender
- The surgery must be elective, meaning it is not an emergency procedure
Main exclusion criteria:
- Presence of cancer or tumors in the kidney or ureter
- Having kidney stones
- Having renal reflux, which is a condition where urine flows backward from the bladder to the kidneys
Focus and goal of the trial:
The main goal of this study is to determine which pain management strategy works best to improve recovery after robot-assisted upper urinary tract surgery. The researchers will measure recovery quality using a patient-centered tool called the Quality of Recovery 15 score. This score helps assess how well patients are recovering by looking at various aspects of their well-being, including pain levels, physical comfort, emotional state, and ability to perform daily activities.
The study will monitor patients at several time points: immediately after surgery in the recovery room, on the first day after surgery, and on days two and three after surgery. The research team will track pain levels, the amount of pain medication needed, any nausea or vomiting, and how quickly patients can get out of bed and return to normal bowel function. They will also watch for any complications up to 30 days after surgery.
Investigational drugs being tested:
The trial is comparing three different pain management approaches:
Bupivacaine: This is a local anesthetic medication that numbs specific areas of the body to relieve pain. In this study, it is given as part of spinal analgesia, which means it is injected near the spinal cord to block pain signals during and after surgery.
Morphine: This is a strong pain reliever from the opioid family. In this trial, it is administered intrathecally, meaning it is injected into the space around the spinal cord. This method allows the medication to work directly on pain pathways in the spine.
Lidocaine: This is another local anesthetic that is commonly used to numb tissue. In this study, it is given intravenously, meaning it is delivered through a vein, to help manage pain throughout the body and potentially improve overall recovery.
Participants will be randomly assigned to receive one of these treatments, and neither the patients nor the medical team will know which treatment each patient receives during the study. This approach helps ensure that the results are not influenced by expectations or bias.
Summary
Currently, there is one clinical trial available for patients with conditions affecting the upper urinary tract, located in Sweden. This trial focuses specifically on improving the surgical recovery experience through optimized pain management strategies. The study is exploring three different approaches using well-established medications: spinal morphine, intravenous lidocaine, and bupivacaine with adrenaline.
The trial is designed to help identify the most effective pain management method for patients undergoing robot-assisted surgery for various urinary tract conditions. While the exclusion criteria specifically mention cancer, kidney stones, and renal reflux, the trial aims to gather valuable information that could benefit a broader range of patients needing similar surgical procedures in the future.
Patients interested in this trial should discuss their eligibility with their healthcare provider, particularly regarding the inclusion and exclusion criteria. The study is expected to continue collecting data through December 2025.
