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

• Sponsor: Southwest Hospital, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02986061
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Catheter	Device: Urinary catheter	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Patients with indwelling urinary catheter	Device: Urinary catheter
No Intervention: Study Group Patients without indwelling urinary catheter

Outcome Measures

Primary Outcome Measures

1. Postoperative urinary retention [7 days]

2. Postoperative urinary tract infection [7 days]

3. Urine volume [3 days]

Secondary Outcome Measures

1. Length of stay [14 days]

2. Intraoperative intravenous fluid [1 day]

3. Duration of the surgery [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Joint Surgery, Southwest Hospital, Third Military Medical University	Chongqing	Chongqing	China	400038

Sponsors and Collaborators

• Southwest Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liu Yang, Director, Southwest Hospital, China
• ClinicalTrials.gov Identifier: NCT02986061
• Other Study ID Numbers: Knee-UC
• First Posted: Dec 8, 2016
• Last Update Posted: Dec 8, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Dec 8, 2016