Comparing spinal morphine and intravenous lidocaine for pain management in robotic kidney surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if adding spinal analgesia improves recovery outcomes for patients undergoing robotic-assisted laparoscopic upper urinary tract surgery. It will assess the effectiveness of spinal morphine and bupivacaine compared to intravenous lidocaine in reducing postoperative pain and enhancing overall recovery as measured by the Quality of Recovery 15 scale. The study will also evaluate the impact on surgical workflow and potential complications associated with spinal analgesia. Participants will be monitored for pain levels, opioid use, and length of hospital stay.

Why it matters

Who can join: the full rules

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, myasthenia gravis, 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

Where it's running

• Länssjukhuset i Kalmar
  Kalmar, Sweden Recruiting
• University Hospital Linköping
  Linköping, Sweden Recruiting
• Centrallasarettet Växjö
  Vaxjo, Sweden Not yet recruiting

Study contacts

• Principal investigator: Martin Holmberg — University Hospital, Linkoeping
• Study coordinator: Hans Bahlmann, MD PhD
• Email: hans.bahlmann@regionostergotland.se
• Phone: +46739312281

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.