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

Sponsor

TriHealth Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT03863743

Collaborator

(none)

164

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Urinary Retention	Other: integrated care pathway Other: physician's standard of care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.164 patients will be randomized to either the control group or the experimental group. Patients will be randomized immediately following the signed consent.

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 5, 2019

Anticipated Primary Completion Date :

Feb 5, 2022

Anticipated Study Completion Date :

Feb 5, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

POUR [up to 24 hours post-op]
presence or absence of urinary retention

Secondary Outcome Measures

opioid consumption [up to 14 days following the joint procedure]
opioid consumption (in morphine milligram equivalents; MME)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TriHealth Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
2	TriHealth Evendale Hospital	Cincinnati	Ohio	United States	45241

Sponsors and Collaborators

TriHealth Inc.

Investigators

Principal Investigator: Mark Snyder, MD, TriHealth Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mark Snyder, Principal Investigator, TriHealth Inc.

ClinicalTrials.gov Identifier:

NCT03863743

Other Study ID Numbers:

18-012

First Posted:

Mar 5, 2019

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Retention

Study Results

No Results Posted as of Mar 1, 2021