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NCT06349668 · ClinicalTrials.gov record · last posted 2026-02-05

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

Study acronym: SMILe
StatusRecruiting
PhasePhase 3
Started2024-04-09
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from the ClinicalTrials.gov record
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.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2024-03-29; most recent amendment 2026-02-02. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-04-09
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT06349668
Lead Sponsor Hans Bahlmann
Collaborators: Linkoeping University
Conditions 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
Enrollment 220 participants
Start Date 2024-04-09
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-05