Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery

Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative Complications; PONV; Quality of Recovery; Urology; Laparoscopic
• Intervention / Treatment: Procedure: Usual care

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Linkoping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult population undergoing elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital, sweden.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group feasibility; Adults undergoing elective urologic laparoscopic robotic surgery.	Procedure: Usual care; Intravenous morphine according to clinician´s discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Recovery 15 (QoR-15) score	Quality of Recovery 15. A total of 15 questions each answered with a value from 0 to 10. The minimum value of the QoR-15 is 0 and the maximum value is 150. A higher value means a better outcome.	Preoperative, postoperative up to day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		Up to 30 days
Postoperative pain	Measurement of pain in rest and in movement with the Numeric Rating Scale (NRS) Pain Scale. Minimum value is 0 (no pain) and maximum value is 10 (extreme pain).	Up to postoperative day 3
PONV	Measurement of the frequency of postoperative nausea and vomiting (PONV).	Up to postoperative day 3
Return of bowel function	Time to first passing of flatus and first passing of stool.	Up to postoperative day 7
Postoperative complications	Using the Clavien-Dindo Classification	Up to postoperative day 30

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Director: Michelle Chew, MD PhD, Linköping University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2020
• Primary Completion (ACTUAL): October 19, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (ACTUAL): January 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 210101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No