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Recruiting Phase 3 NCT06349668

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

Trial Parameters

Condition Other Specified Disorders of Kidney and Ureter
Sponsor Hans Bahlmann
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 220
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-09
Completion 2027-10-01
Interventions
spinal analgesia with morphine and bupivacainelidocaine infusion

Brief Summary

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? * Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications? * Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery? * Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery? Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively. QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary. In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.

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 s

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