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NCT Number: NCT04694950

Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Linkoping University Hospital

Linköping, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

usual care

Procedure

Intravenous morphine according to clinician´s discretion.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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