Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Urinary Retention
Conditions
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).
Interventions
Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.
OTHERphysician's standard of care
Incidence of POUR will be evaluated in standard of care treatment.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POUR | up to 24 hours post-op | presence or absence of urinary retention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption | up to 14 days following the joint procedure | opioid consumption (in morphine milligram equivalents; MME) |
Countries
United States
Contacts
Primary ContactJustin Osborne
Backup ContactGinger LaMar
Outcome results
None listed