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

Urinary Catheter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986061
• Other study ID #: Knee-UC
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: December 7, 2016
• Start date: November 2016

Study information

• Verified date: December 2016
• Source: Southwest Hospital, China
• Contact: Wei-Nan Zeng, MD
• Email: weinanzeng[@]163.com
• Is FDA regulated: No
• Health authority: Third Military Medical University: China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Catheter

Intervention

Device:
• Urinary catheter

Locations

Country	Name	City	State
China	Center for Joint Surgery, Southwest Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative urinary retention		7 days	Yes
Primary	Postoperative urinary tract infection		7 days	Yes
Primary	Urine volume		3 days	Yes
Secondary	Length of stay		14 days	Yes
Secondary	Intraoperative intravenous fluid		1 day	Yes
Secondary	Duration of the surgery		1 day	Yes