Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT06349668
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Sponsor:
Hans Bahlmann
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMILe
Brief 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.
* 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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: