Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-01 @ 1:00 PM
Study NCT ID:
NCT04694950
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2020-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery
Sponsor:
Linkoeping University
Organization:
Study Overview
Official Title:
Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
Previously published studies show that adding intrathecal morphine to general anesthesia can reduce the postoperative pain and length of stay (LOS) in varies types of surgery. A recent meta-analysis showed that the addition of intrathecal morphine at doses below 500µg did not increase the risk of respiratory depression compared with a control group receiving intravenous opioids. Epidural analgesia is uncommonly used for robot-assisted laparoscopic procedures due to the limited surgical trauma. In addition, the risks associated with the epidural itself such as infection and spinal hematoma are thought to outweigh its possible benefits for these procedures.
At Linkoping University Hospital a combination of general anesthesia and intrathecal morphine in robot-assisted laparoscopic radical prostatectomy and in robotic-assisted laparoscopic cystectomy is now routinely used in order to improve postoperative recovery. However whether this approach is beneficial in other types of robotic-assisted urological procedures is unknown.
Therefore the investigators aim to conduct a feasibility study for the use of intrathecal morphine combined with general anaesthesia in adult patients undergoing elective urologic laparoscopic robot-assisted surgery at Linkoping University Hospital. The investigators will include 30 patients in the study. The specific aims are to investigate the feasibility and sensitivity of Quality of Recovery 15 (QoR15), as an outcome tool measuring postoperative well-being in this patient cohort.
The investigators will also investigate the feasibility of other outcome measures such as postoperative pain, post-anesthesia care unit LOS, occurrence of pruritus and hospital LOS.
For planning of the timeframe of the future interventional study the investigators will use this feasibility study to examine the inclusion rate of study patients.
At Linkoping University Hospital a combination of general anesthesia and intrathecal morphine in robot-assisted laparoscopic radical prostatectomy and in robotic-assisted laparoscopic cystectomy is now routinely used in order to improve postoperative recovery. However whether this approach is beneficial in other types of robotic-assisted urological procedures is unknown.
Therefore the investigators aim to conduct a feasibility study for the use of intrathecal morphine combined with general anaesthesia in adult patients undergoing elective urologic laparoscopic robot-assisted surgery at Linkoping University Hospital. The investigators will include 30 patients in the study. The specific aims are to investigate the feasibility and sensitivity of Quality of Recovery 15 (QoR15), as an outcome tool measuring postoperative well-being in this patient cohort.
The investigators will also investigate the feasibility of other outcome measures such as postoperative pain, post-anesthesia care unit LOS, occurrence of pruritus and hospital LOS.
For planning of the timeframe of the future interventional study the investigators will use this feasibility study to examine the inclusion rate of study patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: