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

February 24, 2021 updated by: Mark Snyder, TriHealth Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • Recruiting
        • TriHealth Evendale Hospital
        • Contact:
        • Principal Investigator:
          • Mark Snyder, MD
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Mark Snyder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Investigators

  • Principal Investigator: Mark Snyder, MD, TriHealth Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2019

Primary Completion (Anticipated)

February 5, 2022

Study Completion (Anticipated)

February 5, 2022

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IDP will not be available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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