Clinical trial NCT03863743: Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention (POUR)
Official title: Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention in Primary Total Knee or Total Hip Replacement: Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Urinary Retention
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: POUR
timeFrame: up to 24 hours post-op
Secondary outcomes:
measure: opioid consumption
timeFrame: up to 14 days following the joint procedure
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Evendale Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Mark Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
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