Recruiting

Integrated Care Pathways

Sponsor:

TriHealth Inc.

Code:

NCT03863743

Conditions

Arthroplasty, Replacement, Hip

Arthroplasty, Replacement, Knee

Urinary Retention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

integrated care pathway

physician's standard of care

Study Details

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.

Conditions

Arthroplasty, Replacement, Hip

Arthroplasty, Replacement, Knee

Urinary Retention

Study ID

NCT03863743

Start date

Feb 5, 2019

Status verified date

Feb, 2021

Completion date

Feb 5, 2022

Anticipated

Primary completion date

Feb 5, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Control

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: Experimental

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).

Interventions

integrated care pathway

Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.

physician's standard of care

Incidence of POUR will be evaluated in standard of care treatment.

Primary outcome measure

  • POUR [ Time Frame: up to 24 hours post-op ]

Central Contacts and Locations

Central contacts

Justin Osborne

513-865-5211Justin_Osborne@trihealth.com

Ginger LaMar

513-865-5211Ginger_LaMar@trihealth.com

Locations

TriHealth Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Justin Osborne

513-865-5211justin_osborne@trihealth.com

Principal Investigator:

Mark Snyder, MD

TriHealth Evendale Hospital

Recruiting

Cincinnati, Ohio, United States, 45241

Contacts

Justin Osborne

513-865-5211Justin_Osborne@trihealth.com

Principal Investigator:

Mark Snyder, MD

More Information

Sponsor

TriHealth Inc.

Last update posted

Mar 1, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2021-03-01.