Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694950
• Other study ID #: 210101
• Status: Completed
• Start date: December 30, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2022
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Usual care
Intravenous morphine according to clinician´s discretion.

Locations

Country	Name	City	State
Sweden	Linkoping University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PONV	Measurement of the frequency of postoperative nausea and vomiting (PONV).	Up to postoperative day 3
Secondary	Return of bowel function	Time to first passing of flatus and first passing of stool.	Up to postoperative day 7
Secondary	Postoperative complications	Using the Clavien-Dindo Classification	Up to postoperative day 30
Secondary	Length of hospital stay		Up to 30 days