Authorised Therapeutic confirmatory (Phase III) Renal or ureter malignancy; Renal or ureter benign tumor; Nephrolithiasis; Renal reflux

SMILe: Spinal Morphine or Intravenous Lidocaine in robot-assisted upper urologic surgery

EU CTIS ID: 2023-505941-21-00

What this study is testing

To study whether the addition of spinal analgesia with bupivacaine and morphine in patients having robotic-assisted laparoscopic upper urinary tract surgery in general anesthesia improves recovery after surgery as quantified by the patient-centered outcome scale "Quality of Recovery 15"

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The patient 1) is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals; 2) gives oral and written informed consent after having received oral and written 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 to severe restrictions in vision, hearing, cognition, reading- or Swedish language abilities; the patient is pregnant or lactating or a fertile female (i.e. age < 45 and not sterilised) not using adequate contraception or not recently having had a negative pregnancy test; emergency surgery; research staff not available; 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 obesity, severe scoliosis); the patient has contraindications to lidocaine infusion: proven allergy to local anesthetics, myasthenia gravis, renal failure ( eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher), severe cardiac arrythmias or insufficiency (NYHA IIIb or higher); previous participation in the trial.

The study team makes the final eligibility decision.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.