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To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia

NCT ID: NCT02986061

Last Updated: 2016-12-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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The aim of this study was to investigate whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.

Detailed Description

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Conditions

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Urinary Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Patients with indwelling urinary catheter

Group Type ACTIVE_COMPARATOR

Urinary catheter

Intervention Type DEVICE

Study Group

Patients without indwelling urinary catheter

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Urinary catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period.

Exclusion Criteria

* Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Liu Yang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Joint Surgery, Southwest Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei-Nan Zeng, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Wei-Nan Zeng, MD

Role: primary

Other Identifiers

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Knee-UC

Identifier Type: -

Identifier Source: org_study_id