Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery

NCT ID: NCT04694950

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Recovery Urology Pain PONV Postoperative Complications Laparoscopic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group feasibility

Adults undergoing elective urologic laparoscopic robotic surgery.

Usual care

Intervention Type PROCEDURE

Intravenous morphine according to clinician´s discretion.

Interventions

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Usual care

Intravenous morphine according to clinician´s discretion.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Martin Holmberg

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Chew, MD PhD

Role: STUDY_DIRECTOR

Linkoeping University

Locations

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Linkoping University Hospital

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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210101

Identifier Type: -

Identifier Source: org_study_id

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