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Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04694950
Recruitment Status : Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Martin Holmberg, Linkoeping University

Study Description
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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.


Condition or disease Intervention/treatment
Quality of Recovery Urology Pain PONV Postoperative Complications Laparoscopic Procedure: Usual care

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study
Actual Study Start Date : December 30, 2020
Actual Primary Completion Date : October 19, 2021
Estimated Study Completion Date : December 30, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Group feasibility
Adults undergoing elective urologic laparoscopic robotic surgery.
 Procedure: Usual care
Intravenous morphine according to clinician´s discretion.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Quality of Recovery 15 (QoR-15) score [ Time Frame: Preoperative, postoperative up to day 7 ]
    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.


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: Up to postoperative day 3 ]
    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).

  2. PONV [ Time Frame: Up to postoperative day 3 ]
    Measurement of the frequency of postoperative nausea and vomiting (PONV).

  3. Return of bowel function [ Time Frame: Up to postoperative day 7 ]
    Time to first passing of flatus and first passing of stool.

  4. Postoperative complications [ Time Frame: Up to postoperative day 30 ]
    Using the Clavien-Dindo Classification

  5. Length of hospital stay [ Time Frame: Up to 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult population undergoing elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital, sweden.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694950


Locations
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Sweden
Linkoping University Hospital
Linköping, Sweden
Sponsors and Collaborators
Linkoeping University
Investigators
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Study Director: Michelle Chew, MD PhD Linkoping University
More Information
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Responsible Party: Martin Holmberg, Principal investigator, Linkoeping University
ClinicalTrials.gov Identifier: NCT04694950    
Other Study ID Numbers: 210101
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: December 6, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes