protocolSection identificationModule nctId: NCT06349668, orgStudyIdInfo id: 2023-505941-21-00, briefTitle: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery, acronym: SMILe, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Hans Bahlmann, class: OTHER, collaborators name: Linkoeping University, descriptionModule briefSummary: 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., conditionsModule conditions: Other Specified Disorders of Kidney and Ureter, conditions: Benign Neoplasm of Ureter, conditions: Calculus of Kidney and Ureter, conditions: Ureter Cancer, conditions: Ureteric Reflux, conditions: Congenital Ureteric Anomaly, conditions: Benign Renal Neoplasm, conditions: Renal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: spinal analgesia with morphine and bupivacaine, interventions name: lidocaine infusion, outcomesModule primaryOutcomes measure: QoR-15 score at postoperative day 1, secondaryOutcomes measure: QoR-15 score preoperatively, secondaryOutcomes measure: QoR-15 score at postoperative day 7, secondaryOutcomes measure: Pain (NRS) in rest and during motion 2hrs after arrival to the PACU, secondaryOutcomes measure: Pain (NRS) on POD 1-3, secondaryOutcomes measure: Pain (NRS) in rest and during motion at POD 7, secondaryOutcomes measure: Time from arrival in the OR to start of surgery, secondaryOutcomes measure: Time from end of surgery until leaving the OR, secondaryOutcomes measure: Incidence of unplanned termination of the lidocaine infusion, secondaryOutcomes measure: Amount of remifentanil in patients given remifentanil, secondaryOutcomes measure: Amount of intraoperative opioids in patients not receiving remifentanil, secondaryOutcomes measure: Length of stay at the PACU, secondaryOutcomes measure: Amount of opioids administred at the PACU, secondaryOutcomes measure: Percentage of patients with PONV requiring treatment at 0-6 hours and 6-24 hours postoperatively as well as during the whole postoperative stay, secondaryOutcomes measure: "Time out-of-bed" on POD 1-3, secondaryOutcomes measure: Amount of opioids administered during the first 24 hours at the ward, secondaryOutcomes measure: First POD passing gases, secondaryOutcomes measure: First POD passing stool, secondaryOutcomes measure: Incidence of pruritus, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: DAOH30, secondaryOutcomes measure: Postoperative complications untill POD 30, secondaryOutcomes measure: Requirement for opioids after discharge, secondaryOutcomes measure: Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hours of induction of anesthesia, secondaryOutcomes measure: Intraoperative fluid balance, secondaryOutcomes measure: Time with low blood pressure during anesthesia, secondaryOutcomes measure: Lowest MAP within 10 minutes after induction of anesthesia, secondaryOutcomes measure: Highest MAP within 10 minutes of abdominal insufflation, secondaryOutcomes measure: Fraction of patients needing norepinephrine before start of surgery, secondaryOutcomes measure: Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of surgery), secondaryOutcomes measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, before start of surgery, secondaryOutcomes measure: Average infusion rate of norepinephrine, in patients receiving norepinephrine, after start of surgery, secondaryOutcomes measure: Intraoperative Cardiac Index, secondaryOutcomes measure: Intraoperative Stroke Volume Index, secondaryOutcomes measure: Intraoperative Cardiac Power Index, secondaryOutcomes measure: Intraoperative dPmx, secondaryOutcomes measure: Intraoperative Pulse Pressure Variation, secondaryOutcomes measure: Intraoperative Stroke Volume Variation, secondaryOutcomes measure: Intraoperative Systemic Vascular Resistance Index, secondaryOutcomes measure: Intraoperative heart rate, secondaryOutcomes measure: Biochemical markers of inflammation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Linköping, status: RECRUITING, city: Linköping, country: Sweden, contacts name: Martin Holmberg, MD, role: CONTACT, phone: +46101033932, email: martin.holmberg@regionostergotland.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False