Clinical trial NCT04694950: Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery
Official title: Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Recovery
Urology
Pain
PONV
Postoperative Complications
Laparoscopic
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2021-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population undergoing elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital, sweden.

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.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital

Exclusion Criteria:

* Age \<18
* Not expected to comprehend the written or verbal study information
* Patient planned for robotic assisted laparoscoic prostatectomy or robotic assisted laparoscopic cystectomy
* Acute surgery
* ASA class \>3
* Major surgery on another organ planned at the same operation
* Patient planned for a neuraxial blockade in addition to general anaesthesia.
* Study personal not available

Primary outcomes:
measure: Change in Quality of Recovery 15 (QoR-15) score
timeFrame: Preoperative, postoperative up to day 7
Secondary outcomes:
measure: Postoperative pain
timeFrame: Up to postoperative day 3
measure: PONV
timeFrame: Up to postoperative day 3
measure: Return of bowel function
timeFrame: Up to postoperative day 7
measure: Postoperative complications
timeFrame: Up to postoperative day 30
measure: Length of hospital stay
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linkoping University Hospital
Study officials:
affiliation: Linkoeping University
name: Michelle Chew, MD PhD
role: STUDY_DIRECTOR
References: