Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT06349668
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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 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 and cannot provide a negative pregnancy test
* 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 obesity, severe scoliosis)
* The patient has clear contraindications to lidocaine infusion, e.g. proven allergy to local anesthetics, renail failure (eGFR \< 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher, severe cardiac arrythmias or insuffiency (NYHA IIIb or higher)
* The patient has previously participated in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06349668
Study Brief:
Protocol Section:
NCT06349668