Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349668
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-24
Brief Title:
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Sponsor:
Hans Bahlmann
Organization:
University Hospital Linkoeping
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 80 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 80 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:
None
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?:
None