Effekten av Intratekalt Morfin Eller intravenöst Lidokain på Postoperativ återhämtning Efter Robotassisterad övre Urologisk Kirurgi. Randomiserad Assessor-blindad Multicenterstudie. SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals

• The patient gives oral and written informed consent after having received oral and writen information about the study

Locations
Other Locations
Sweden
University Hospital Linköping
RECRUITING
Linköping
Contact Information
Primary
Hans Bahlmann, MD PhD
hans.bahlmann@regionostergotland.se
+46739312281
Backup
Martin Holmberg, MD
martin.holmberg@regionostergotland.se
+46101033932
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 220
Treatments
Experimental: spinal analgesia
single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
Active_comparator: lidocaine infusion
intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t (Ideal Body Weight)
Sponsors
Collaborators: Linkoeping University
Leads: Hans Bahlmann

This content was sourced from clinicaltrials.gov

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