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

Study acronym: SMILe
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Primary completion date: Oct 1, 2026 to Oct 1, 2027v4 Show 5 more changesShow less
    • Study sites: 1 to 3
    • Study completion date: Dec 1, 2026 to Dec 31, 2027
    • Secondary endpoints revised (41)
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 4 words
  2. Minor Secondary endpoints: 40 to 41v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2024 to Apr 9, 2024
    • Interventions: lidocaine infusion (Drug), spinal analgesia (Drug) to lidocaine infusion (Drug), spinal analgesia with morphine and bupivacaine (Drug)
    • Secondary endpoints: 37 to 40
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06349668
Lead Sponsor Hans Bahlmann
Collaborators: Linkoeping University
Conditions
(from sponsor)
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter, Calculus of Kidney and Ureter, Ureter Cancer, Ureteric Reflux, Congenital Ureteric Anomaly, Benign Renal Neoplasm, Renal Cancer
Related terms Kidney Neoplasms, Nephrolithiasis, Ureteral Neoplasms, Vesico-Ureteral Reflux
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov