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New treatment option for Other Specified Disorders of Kidney and Ureter
Official title Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
ClinicalTrials.gov ID: NCT06349668
What this study is testing
What is spinal analgesia with morphine and bupivacaine?
spinal analgesia with morphine and bupivacaine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for other specified disorders of kidney and ureter.
Also referred to as morphine spinal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are: Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals
- The patient gives oral and written informed consent after having received oral and writen information about the study
You likely can't join if
- The patient has a ASA-class of IV or above
- The patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due...
- The patient is a female who is pregnant or breastfeeding
- The patient is a pre-menopausal female who has not undergone sterilisation, hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, and...
- The patient is scheduled for emergency surgery
- Research staff not available
See the full eligibility criteria
- The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals
- The patient gives oral and written informed consent after having received oral and writen information about the study
- The patient has a ASA-class of IV or above
- The patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due to severe restrictions in vision, hearing, cognition, reading or...
- The patient is a female who is pregnant or breastfeeding
- The patient is a pre-menopausal female who has not undergone sterilisation, hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, and is not using highly-effective contraception with low user-dependency...
- The patient is scheduled for emergency surgery
- Research staff not available
- Scheduled significant simultaneous surgery on another organ
- The anesthesiologist in charge has planned spinal or epidural analgesia
- The patient has clear contraindications to spinal analgesia, e.g. severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or spinal analgesia can be expected to be technically challenging (severe...
- The patient has clear contraindications to lidocaine infusion, e.g. proven allergy to local anesthetics, myasthenia gravis, renail failure (eGFR \< 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh...
- The patient has previously participated in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Kalmar, Sweden
- Linköping, Sweden
- Vaxjo, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kalmar, Sweden; Linköping, Sweden; Vaxjo, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.