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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention in Primary Total Knee or Total Hip Replacement: Prospective Randomized Control Trial

Conditions
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Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Urinary Retention

Intervention / Treatment
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* Other: integrated care pathway
* Other: physician's standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 164 patients will be randomized to either the control group or the experimental group. Patients will be randomized immediately following the signed consent.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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). | Other: physician's standard of care<br>* Incidence of POUR will be evaluated in standard of care treatment.<br>|
| Experimental: Experimental<br>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). | Other: integrated care pathway<br>* Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POUR | presence or absence of urinary retention | up to 24 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | opioid consumption (in morphine milligram equivalents; MME) | up to 14 days following the joint procedure |