search
Back to results

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

Primary Purpose

Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Urinary Retention

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
integrated care pathway
physician's standard of care
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthroplasty, Replacement, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TriHealth Good Samaritan HospitalRecruiting
  • TriHealth Evendale HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Experimental

Arm 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).

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).

Outcomes

Primary Outcome Measures

POUR
presence or absence of urinary retention

Secondary Outcome Measures

opioid consumption
opioid consumption (in morphine milligram equivalents; MME)

Full Information

First Posted
March 3, 2019
Last Updated
February 24, 2021
Sponsor
TriHealth Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03863743
Brief Title
Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention (POUR)
Acronym
POUR
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
February 5, 2022 (Anticipated)
Study Completion Date
February 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TriHealth Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Urinary Retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm 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).
Arm Title
Experimental
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
integrated care pathway
Intervention Description
Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.
Intervention Type
Other
Intervention Name(s)
physician's standard of care
Intervention Description
Incidence of POUR will be evaluated in standard of care treatment.
Primary Outcome Measure Information:
Title
POUR
Description
presence or absence of urinary retention
Time Frame
up to 24 hours post-op
Secondary Outcome Measure Information:
Title
opioid consumption
Description
opioid consumption (in morphine milligram equivalents; MME)
Time Frame
up to 14 days following the joint procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Osborne
Phone
513-865-5211
Email
Justin_Osborne@trihealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ginger LaMar
Phone
513-865-5211
Email
Ginger_LaMar@trihealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Snyder, MD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriHealth Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Osborne
Phone
513-865-5211
Email
justin_osborne@trihealth.com
First Name & Middle Initial & Last Name & Degree
Mark Snyder, MD
Facility Name
TriHealth Evendale Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Osborne
Phone
513-865-5211
Email
Justin_Osborne@trihealth.com
First Name & Middle Initial & Last Name & Degree
Mark Snyder, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IDP will not be available to other researchers
Citations:
PubMed Identifier
26091224
Citation
Hollman F, Wolterbeek N, Veen R. Risk Factors for Postoperative Urinary Retention in Men Undergoing Total Hip Arthroplasty. Orthopedics. 2015 Jun;38(6):e507-11. doi: 10.3928/01477447-20150603-59.
Results Reference
background
PubMed Identifier
26731878
Citation
Umer A, Ross-Richardson C, Ellner S. Incidence and Risk Factors for Postoperative Urinary Retention: A Retrospective, Observational Study with a Literature Review of Preventive Strategies. Conn Med. 2015 Nov-Dec;79(10):587-92.
Results Reference
background
PubMed Identifier
19352147
Citation
Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
Results Reference
background
Citation
Cronin JJ, Shannon FJ, Bale E, Quinlan W. Prediction of post-operative urinary retention in hip and knee arthroplasty in a male population. European Journal of Orthopaedic Surgery & Traumatology. 2007;17(1):47-50.
Results Reference
background
PubMed Identifier
26153208
Citation
Fazeli F, Gooran S, Taghvaei ME, Fazeli K. Evaluating International Prostate Symptom Score (IPSS) in Accuracy for Predicting Post-Operative Urinary Retention After Elective Cataract Surgery: A Prospective Study. Glob J Health Sci. 2015 Mar 26;7(7 Spec No):93-6. doi: 10.5539/gjhs.v7n7p93.
Results Reference
background
PubMed Identifier
27286124
Citation
Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256.
Results Reference
background
PubMed Identifier
12578033
Citation
Brouwer TA, Eindhoven BG, Epema AH, Henning RH. Validation of an ultrasound scanner for determing urinary volumes in surgical patients and volunteers. J Clin Monit Comput. 1999 Aug;15(6):379-85. doi: 10.1023/a:1009939530626.
Results Reference
background
PubMed Identifier
26453530
Citation
Tischler EH, Restrepo C, Oh J, Matthews CN, Chen AF, Parvizi J. Urinary Retention is Rare After Total Joint Arthroplasty When Using Opioid-Free Regional Anesthesia. J Arthroplasty. 2016 Feb;31(2):480-3. doi: 10.1016/j.arth.2015.09.007. Epub 2015 Sep 18.
Results Reference
background
PubMed Identifier
27592218
Citation
Gerrard AD, Brooks B, Asaad P, Hajibandeh S, Hajibandeh S. Meta-analysis of epidural analgesia versus peripheral nerve blockade after total knee joint replacement. Eur J Orthop Surg Traumatol. 2017 Jan;27(1):61-72. doi: 10.1007/s00590-016-1846-z. Epub 2016 Sep 3.
Results Reference
background
PubMed Identifier
27824434
Citation
Dysart S, Snyder MA, Mont MA. A Randomized, Multicenter, Double-Blind Study of Local Infiltration Analgesia with Liposomal Bupivacaine for Postsurgical Pain Following Total Knee Arthroplasty: Rationale and Design of the Pillar Trial. Surg Technol Int. 2016 Nov 11;30:261-267.
Results Reference
background
PubMed Identifier
28802777
Citation
Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. Erratum In: J Arthroplasty. 2019 Feb;34(2):399-400.
Results Reference
background
PubMed Identifier
23937923
Citation
Backes JR, Bentley JC, Politi JR, Chambers BT. Dexamethasone reduces length of hospitalization and improves postoperative pain and nausea after total joint arthroplasty: a prospective, randomized controlled trial. J Arthroplasty. 2013 Sep;28(8 Suppl):11-7. doi: 10.1016/j.arth.2013.05.041. Epub 2013 Aug 9.
Results Reference
background
PubMed Identifier
28326395
Citation
Snyder MA, Scheuerman CM, Gregg JL, Ruhnke CJ, Eten K. Improving total knee arthroplasty perioperative pain management using a periarticular injection with bupivacaine liposomal suspension. Arthroplast Today. 2016 Jan 11;2(1):37-42. doi: 10.1016/j.artd.2015.05.005. eCollection 2016 Mar.
Results Reference
background
PubMed Identifier
27746750
Citation
Boonstra AM, Stewart RE, Koke AJ, Oosterwijk RF, Swaan JL, Schreurs KM, Schiphorst Preuper HR. Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence of Sex and Catastrophizing. Front Psychol. 2016 Sep 30;7:1466. doi: 10.3389/fpsyg.2016.01466. eCollection 2016.
Results Reference
background
PubMed Identifier
20150853
Citation
Balderi T, Carli F. Urinary retention after total hip and knee arthroplasty. Minerva Anestesiol. 2010 Feb;76(2):120-30.
Results Reference
background
PubMed Identifier
17031312
Citation
Maheshwari AV, Boutary M, Yun AG, Sirianni LE, Dorr LD. Multimodal analgesia without routine parenteral narcotics for total hip arthroplasty. Clin Orthop Relat Res. 2006 Dec;453:231-8. doi: 10.1097/01.blo.0000246545.72445.c4.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs