RecruitingPhase 3NCT06349668

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

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


Sponsor

Hans Bahlmann

Enrollment

220 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two pain management approaches for people undergoing robot-assisted kidney or urinary tract surgery: a spinal injection of morphine versus lidocaine given through an IV, to determine which provides better pain relief after surgery. **You may be eligible if...** - You are scheduled for elective robotic-assisted surgery on the upper urinary tract (such as kidney or ureter) at a participating hospital - You can provide written and verbal informed consent **You may NOT be eligible if...** - You have a very serious systemic illness (ASA class IV or higher) - You are a minor or have severe psychiatric illness - You have significant problems with vision, hearing, or cognition that prevent you from understanding study information - You cannot read Swedish (as the study is conducted in Sweden) - You are pregnant or breastfeeding - You are a pre-menopausal woman not using reliable contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGspinal analgesia with morphine and bupivacaine

single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery

DRUGlidocaine 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)


Locations(3)

Länssjukhuset i Kalmar

Kalmar, Sweden

University Hospital Linköping

Linköping, Sweden

Centrallasarettet Växjö

Vaxjo, Sweden

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NCT06349668


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