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

Arthroplasty, Replacement, Knee Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863743
• Other study ID #: 18-012
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: February 5, 2022

Study information

• Verified date: February 2021
• Source: TriHealth Inc.
• Contact: Justin Osborne
• Phone: 513-865-5211
• Email: Justin_Osborne[@]trihealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 integrated care pathway.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: February 5, 2022
• Est. primary completion date: February 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• integrated care pathway
Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.
• physician's standard of care
Incidence of POUR will be evaluated in standard of care treatment.

Locations

Country	Name	City	State
United States	TriHealth Evendale Hospital	Cincinnati	Ohio
United States	TriHealth Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View 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. — View Citation

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

Boonstra AM, Stewart RE, Köke 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. eCollection 2016. — View 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. — View 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.

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POUR	presence or absence of urinary retention	up to 24 hours post-op
Secondary	opioid consumption	opioid consumption (in morphine milligram equivalents; MME)	up to 14 days following the joint procedure