NCT03863743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2022

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

March 3, 2019

Last Update Submit

February 24, 2021

Conditions

Arthroplasty, Replacement, HipArthroplasty, Replacement, KneeUrinary Retention

Outcome Measures

Primary Outcomes (1)

  • POUR

    presence or absence of urinary retention

    up to 24 hours post-op

Secondary Outcomes (1)

  • opioid consumption

    up to 14 days following the joint procedure

Study Arms (2)

Control

OTHER

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

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

Interventions

integrated care pathwayOTHER

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

Experimental
physician's standard of careOTHER

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA grade I- III
  • BMI under 36 kg/m\^2
  • Scheduled surgery for primary total hip or knee replacement
  • Age 18+ years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

RECRUITING

TriHealth Evendale Hospital

Cincinnati, Ohio, 45241, United States

RECRUITING

Related Publications (16)

  • 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.

    PMID: 26091224BACKGROUND

  • 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.

    PMID: 26731878BACKGROUND

  • 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.

    PMID: 19352147BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 26153208BACKGROUND

  • 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.

    PMID: 27286124BACKGROUND

  • 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.

    PMID: 12578033BACKGROUND

  • 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.

    PMID: 26453530BACKGROUND

  • 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.

    PMID: 27592218BACKGROUND

  • 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.

    PMID: 27824434BACKGROUND

  • 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.

    PMID: 28802777BACKGROUND

  • 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.

    PMID: 23937923BACKGROUND

  • 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.

    PMID: 28326395BACKGROUND

  • 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.

    PMID: 27746750BACKGROUND

  • Balderi T, Carli F. Urinary retention after total hip and knee arthroplasty. Minerva Anestesiol. 2010 Feb;76(2):120-30.

    PMID: 20150853BACKGROUND

  • 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.

    PMID: 17031312BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mark Snyder, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Osborne

CONTACT

513-865-5211Justin_Osborne@trihealth.com

Ginger LaMar

CONTACT

513-865-5211Ginger_LaMar@trihealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 164 patients will be randomized to either the control group or the experimental group. Patients will be randomized immediately following the signed consent.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2019

First Posted

March 5, 2019

Study Start

February 5, 2019

Primary Completion

February 5, 2022

Study Completion

February 5, 2022

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

IDP will not be available to other researchers

Locations

US(2)