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

TriHealth

Status: Unknown

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

Treatments: Other: physician's standard of care; Other: integrated care pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT03863743

18-012

Details and patient eligibility

About

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.

Full 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).

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Control

Other group

Description:

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).

Treatment:

Other: physician's standard of care

Experimental

Experimental group

Description:

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).

Treatment:

Other: integrated care pathway