Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery

NCT04694950 | Completed

• 1 other identifier: 210101
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Recovery; Urology; Pain; PONV; Postoperative Complications; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pain

  Up to postoperative day 3

• PONV

  Up to postoperative day 3

• Return of bowel function

  Up to postoperative day 7

• Postoperative complications

  Up to postoperative day 30

• Length of hospital stay

  Up to 30 days

Study Arms (1)

Group feasibility

Adults undergoing elective urologic laparoscopic robotic surgery.

Procedure: Usual care

Interventions

Usual care PROCEDURE

Intravenous morphine according to clinician´s discretion.

Group feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoping University Hospital

Linköping, Sweden

Location

MeSH Terms

Conditions

Pain; Postoperative Nausea and Vomiting; Postoperative Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Michelle Chew, MD PhD

  Linkoeping University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: December 30, 2020
• Primary Completion: October 19, 2021
• Study Completion: November 30, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)