NCT06349668

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Hans Bahlmann · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Please refer to CTIS

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

Interventions

Type	Name	Description
DRUG	spinal analgesia with morphine and bupivacaine	single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
DRUG	lidocaine infusion	intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t after a bolus of 2 mg/kg (Ideal Body Weight if BMI \> 22, otherwise ABW)

Timeline

• Start date: 2024-04-09
• Primary completion: 2027-10-01
• Completion: 2027-12-31
• First posted: 2024-04-05
• Last updated: 2026-02-05

Locations

3 sites across 1 country: Sweden