Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention (POUR)

Not Applicable

• Conditions: Arthroplasty, Replacement, Knee; Urinary Retention; Arthroplasty, Replacement, Hip
• Interventions: Other: physician's standard of care; Other: integrated care pathway

• Registration Number: NCT03863743
• Lead Sponsor: TriHealth Inc.

Brief Summary

A prospective randomized control trial will be conducted at Good Samaritan Hospital and TriHealth Evendale Hospital. Subjects will receive total hip or knee surgery and follow-up via standard care at the discretion of the treating physician or the experimental study arm in which all patients will undergo the integrated care pathway.

Detailed Description

Patients will be randomized to the control group or the experimental group. Patients in the control group will receive the treating physician's standard of care, and undergo bladder scans in the post anesthesia care unit (PACU), upon admission to the unit, and prior to discharge from the hospital. Patients in the experimental group will undergo a multimodal pain control care pathway that minimizes opioid consumption.

The primary endpoint will be the presence of or absence of post-operative urinary retention (POUR) between discharge from the PACU and prior to discharge from the hospital. POUR will be defined as bladder volume of greater than 500cc and the inability to void for at least 2 hours within the first 24 hours. POUR, once identified will be treated with intermittent straight catheterization (ISC). Secondary endpoints will include opioid consumption (in morphine milligram equivalents; MME), genito-urinary consultation, type (knee or hip) and duration of surgery, type of anesthesia, duration of anesthesia, total amount of IV fluids, blood loss, length of hospital stay (LOS), discharge status (home with early outpatient physical therapy, etc.), time of first spontaneous voiding, and the number of ISCs and any necessary indwelling catheterization and adverse events of interest including POUR, post-operative nausea and vomiting (PONV), severe pain of 7 or greater on the numeric rating scale(NRS), blood loss requiring transfusion, and lower urinary tract symptoms (LUTS).

Study Timeline

• Study Start: 2019-02-05
• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-01
• Primary Completion: 2022-02-05
• Study Completion: 2022-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• ASA grade I- III
• BMI under 36 kg/m^2
• Scheduled surgery for primary total hip or knee replacement
• Age 18+ years

Exclusion Criteria

• Contraindications or failure of neuraxial anesthesia
• Patients must not be outpatient total hip or knee procedure
• Known intercurrent UTI, incontinence, or urinary retention not addressed by pre-operative urologic consultation and correction
• Pregnancy
• Current nicotine, alcohol or drug abusers
• Pre-operative narcotic use (any narcotic consumption within 3 days prior to surgery)
• Post- operative parenteral narcotic administration
• Allergy or intolerance to liposomal bupivacaine, bupivacaine, celecoxib, dexamethasone and/or pregabalin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	physician's standard of care	Patient will complete IPSS score, medical history, and risk factors for POUR will be evaluated. Patient will undergo treating physician's standard of care for total hip or knee replacement. Patient will receive bladder scans in PACU, upon admission to the nursing unit, and prior to discharge (post-void).
Experimental	integrated care pathway	Patient will complete IPSS score, medical history, and risk factors for POUR will be evaluated. If considered high risk (determined by IPSS), then patient Patient will undergo integrated care pathway that avoids narcotics. Bladder volume will be measured in PACU, after admission to the nursing unit, and prior to discharge from the hospital (post-void).

Primary Outcome Measures

Name	Time	Method
POUR	up to 24 hours post-op	presence or absence of urinary retention

Secondary Outcome Measures

Name	Time	Method
opioid consumption	up to 14 days following the joint procedure	opioid consumption (in morphine milligram equivalents; MME)

Trial Locations

Locations (2)

TriHealth Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

TriHealth Evendale Hospital; 🇺🇸 Cincinnati, Ohio, United States