Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Launched by HANS BAHLMANN · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether adding spinal analgesia (a type of pain relief given through the spine) improves recovery for patients undergoing robotic-assisted surgery on the upper urinary tract. The researchers want to find out if patients who receive spinal analgesia feel better and recover faster compared to those who receive an intravenous pain relief option called lidocaine. They will measure recovery using a specific questionnaire and track pain levels, nausea, and the need for additional pain medications before and after surgery.

To participate, individuals need to be scheduled for elective robotic-assisted surgery and able to provide consent. However, some people may not be eligible, such as those with severe health issues, pregnant or breastfeeding women, or those who have had certain previous surgeries. Participants in the study will be randomly assigned to one of the two pain relief methods and will keep a pain diary to help track their recovery. It’s important for potential participants to know that their progress will be monitored closely, helping doctors better understand the benefits of spinal analgesia in this type of surgery.

Gender

ALL

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