Arthroplasty, Replacement, HipPOURNCT03863743
Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention (POUR)
A study testing integrated care pathway in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by TriHealth Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Urinary Retention
- What is being tested?
- integrated care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2019to 5 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grade I- III
- BMI under 36 kg/m^2
- Scheduled surgery for primary total hip or knee replacement
- Age 18+ years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
Justin Osborne, 513-865-5211, justin_osborne@trihealth.com
Mark Snyder, MD
- Recruiting
TriHealth Evendale Hospital
Cincinnati, Ohio, 45241
Justin Osborne, 513-865-5211, Justin_Osborne@trihealth.com
Mark Snyder, MD
About this study
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
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.
Read the 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).
- Being tested
- integrated care pathway, physician's standard of care
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated care pathwayOther
Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.
physician's standard of careOther
Incidence of POUR will be evaluated in standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: integrated care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
POUR
presence or absence of urinary retention
Measured: up to 24 hours post-op
Secondary outcomes (1)
opioid consumption
opioid consumption (in morphine milligram equivalents; MME)
Measured: up to 14 days following the joint procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start5 Feb 2019
- Primary completion5 Feb 2022 (estimated)
- Study completion5 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Snyder, TriHealth Inc.
- Investigators
- Mark Snyder, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863743
- Sponsor's protocol ID
- 18-012
- Acronym
- POUR
- Status last verified
- Feb 2021
- First submitted
- 3 Mar 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be available to other researchers
Publications
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.
PubMed 26091224Umer 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.
PubMed 26731878Baldini 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.
PubMed 19352147Cronin 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.
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.
PubMed 26153208Akkoc 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.
PubMed 27286124Brouwer 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.
PubMed 12578033Tischler 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.
PubMed 26453530Gerrard 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.
PubMed 27592218Dysart 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.
PubMed 27824434Mont 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.
PubMed 28802777Backes 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.
PubMed 23937923Snyder 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.
PubMed 28326395Boonstra 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.
PubMed 27746750Balderi T, Carli F. Urinary retention after total hip and knee arthroplasty. Minerva Anestesiol. 2010 Feb;76(2):120-30.
PubMed 20150853
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03863743
- Acronym / sponsor ID
- POUR / 18-012
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 5 Feb 2022 (estimated)
- Study completion
- 5 Feb 2022 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: physician's standard of carePatient 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 | Other: integrated care pathwayPatient 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA grade I- III
- BMI under 36 kg/m^2
- Scheduled surgery for primary total hip or knee replacement
- Age 18+ years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated care pathwayIncidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated. | Other | Experimental |
| physician's standard of careIncidence of POUR will be evaluated in standard of care treatment. | Other | Control |
Primary outcome
POUR
Time frame: up to 24 hours post-op
presence or absence of urinary retention
1 secondary outcome
opioid consumption
Time frame: up to 14 days following the joint procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 26091224Hollman 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.
- Background: PubMed 26731878Umer 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.
- Background: PubMed 19352147Baldini 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.
- BackgroundCronin 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: PubMed 26153208Fazeli 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.
- Background: PubMed 27286124Akkoc 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.
- Background: PubMed 12578033Brouwer 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.
- Background: PubMed 26453530Tischler 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.
- Background: PubMed 27592218Gerrard 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.
- Background: PubMed 27824434Dysart 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.
- Background: PubMed 28802777Mont 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.
- Background: PubMed 23937923Backes 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.
- Individual participant dataSharing planned: No. IDP will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Snyder, MD principal investigator
TriHealth Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated care pathway in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by TriHealth Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Osborne (513-865-5211, Justin_Osborne@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POUR (time frame: up to 24 hours post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03863743, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.