- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05969145
The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention (PUR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Orthopedic surgery is a surgical treatment method based on the correction of the functions of bones, November muscles, tendons, and ligaments in the body. Arthroplasty (hip, knee, shoulder), arthroscopy (meniscopathy, rotator cuff rupture), limb fractures, structural (hallux vagus, hallux rigidities, carpal tunnel syndrome, trigger finger), and developmental (hip dysplasia) dysfunctions are the interventions in which the orthopedic surgical procedure is performed. In orthopedic surgeries, the need for surgical treatment increases every day as a result of degeneration in the musculoskeletal system with a decrease in mobilization due to advancing age, November illness, trauma, or technological developments. In the United States, 30% of major surgical interventions involve orthopedic surgeries performed on elderly individuals); in Turkey, it is reported that 33.5% of orthopedic surgeries are performed due to trauma, and about 48% are performed on the lower extremities. Orthopedic surgeries are practices that risk serious complications, as with any treatment option. Complications such as nausea, vomiting, headache, hypotension, and postoperative urinary retention (PUR), especially due to spinal anesthesia, may be observed in patients receiving treatment due to orthopedic surgery. While the prevalence of PUR in orthopedic surgeries is 6-40% in the literature, it is stated that this rate is higher (6-60%) after spinal anesthesia. Due to PUR after orthopedic surgery, there is an increase in hospital stay times, susceptibility to infection, deterioration in the quality of life, and associated cost increases.
Postoperative urinary retention is a complication that manifests symptoms with problems such as suprapubic pain, bladder spasm, and/or inability to urinate after surgical treatment. The etiology of PUR includes factors caused by the patient (advanced age, male gender, anatomical problems, comorbidity, neural transmission disorders), due to the surgical process (failure to empty the bladder during the preoperative period, surgery lasts longer than 2 hours, emergency surgery, opioid-NSAID-atropine use, amount of fluid taken) and due to anesthesia (epidural/spinal anesthesia). 2-6 of the postoperative period. it gives symptoms as a result of the absence of the first urine decrement between hours. As a result, serious problems such as increased urinary pressure and acute kidney injury and/or dysfunction due to bladder distension occur in patients. Management of PUR can be achieved by using physical examination (globe monitoring), bladder catheterization, and ultrasonographic (USG) methods to diagnose these problems at an early stage.
Field health professionals, who have an important place in the conduct of health services, offer the greatest contribution to the surgical treatment process with their understanding of quality health care. In particular, nurses who are actively involved in the perioperative process are the professional staff with the greatest responsibility for positively managing health care. Nurses help to ensure the patient's comfort as soon as possible by providing multidisciplinary cooperation in the management of complications that develop during this process. For this purpose, nurses need to carry out the necessary practices and precautions against the risk of developing PUR, which is one of the postoperative complications. In the recently published Nursing Regulation, the nurses' authority to manage PUR is clearly stated as "interventions to be implemented by a nursing decision" as "A nurse can decide independently or jointly with a physician to insert and remove a urinary catheter if she cannot eliminate urinary retention with the interventions she can apply", "Hot-cold application" intervention definition is clearly stated. Therefore, nurses evaluate the patient by reviewing the existing risk factors of the patient and surgical process during the perioperative period, providing emotional support for surgical stress, questioning perioperative fluid intake, informing the patient about the consumption of caffeine-containing drinks and plenty of water, monitor urine postoperatively, prefer non-invasive methods (listening to water sound, relaxation, bladder massage, mobilization, hot-cold application, ko mot/duck/sliders) primarily in case of PURE development, and invasive methods as a last resort (urinary catheterization, ensuring the necessary cooperation with the physician for interventional applications is one of the important responsibilities in process management. In the literature, it is stated that hot-cold application with bladder catheterization, one of the invasive methods, and hot-water insertion of the hand, massage, mobilization, promotion of liquid and coffee consumption, pelvic muscle exercise, and acupuncture are used in the management of PUR. In the studies conducted, the first postoperative urine output time was reduced by sacral massage in the management of PUR nurses; there was a rapid and permanent decrease in the development of PUR accompanied by the urination algorithm from 21% to 3% observed. However, 59.5% of patients with a hot compress applied to the bladder and 71.4% with cold application had urinary retention regressed; a significant difference in the severity of urinary retention was revealed by hot application; it is reported that urinary catheterization after the hot application is applied to only 3.9% of the patients. Based on these results, it is seen that the practices used by nurses to prevent and manage PUR have resulted in positive outcomes; the hot and cold practice has also made significant contributions to PUR management. For this purpose, it is envisaged that our study will contribute to the effective management of hot-cold application of PUR to the bladder in orthopedic surgery patients, to the minimum preference of invasive applications, to increasing the awareness of nurses about PUR management, and to the literature.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Ankara Yildirim Beyazit University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18 years of age,
- no urinary catheter inserted during the perioperative process, conscious and orientated,
- no renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
- voluntary acceptance to participate in the study.
Exclusion Criteria:
- <18 years of age,
- intellectual disability or perception problem,
- communication disability,
- renal disease (chronic kidney failure, nephropathy, kidney transplantation, prostate, urinary tract infection, history of stones in the urinary system)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hot-cold application
This group will be given a hot cold application to the bladder
|
The experimental group will be given hot and cold application to the bladder
|
|
No Intervention: control group
Routine clinical functioning will be applied to this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physiological parameter, questionnaire
Time Frame: the first 6 hours of the postoperative period
|
prevention of postoperative urinary retention by applying hot and cold to the bladder
|
the first 6 hours of the postoperative period
|
Collaborators and Investigators
Investigators
- Study Director: Gulay Yazici, Assoc. Dr.
Publications and helpful links
General Publications
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- David M, Arthur E, Dhuck R, Hemmings E, Dunlop D. High rates of postoperative urinary retention following primary total hip replacement performed under combined general and spinal anaesthesia with intrathecal opiate. J Orthop. 2015 Nov 18;12(Suppl 2):S157-60. doi: 10.1016/j.jor.2015.10.020. eCollection 2015 Dec.
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- Balderi T, Mistraletti G, D'Angelo E, Carli F. Incidence of postoperative urinary retention (POUR) after joint arthroplasty and management using ultrasound-guided bladder catheterization. Minerva Anestesiol. 2011 Nov;77(11):1050-7. Epub 2011 May 11.
- Bjerregaard LS, Bogo S, Raaschou S, Troldborg C, Hornum U, Poulsen AM, Bagi P, Kehlet H. Incidence of and risk factors for postoperative urinary retention in fast-track hip and knee arthroplasty. Acta Orthop. 2015 Apr;86(2):183-8. doi: 10.3109/17453674.2014.972262. Epub 2014 Oct 10.
- Lior Y, Haim S, Katz I, Danino B, Bar-Yosef Y, Ekstein M. Postoperative Urinary Catheterization in Children Treated with or without Epidural Analgesia after Orthopedic Surgery: A Retrospective Review of Practice. Children (Basel). 2022 Aug 29;9(9):1316. doi: 10.3390/children9091316.
- Zelmanovich A, Fromer DL. (2018). Urinary Retention after Orthopedic Surgery: Identification of Risk Factors and Management. J Clin Exp Orthop, 4(1):54. doi:10.4172/2471-8416.100054.
- Cakmak M, Yildiz M, Akarken I, Karaman Y, Cakmak O. (2020). Risk Factors for Postoperative Urinary Retention in Surgical Population: A Prospective Cohort Study. J Urol Surg, 7(2): 144-148. doi: 10.4274/jus.galenos.2020.3544.
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- Irish Surgical Research Collaborative; Croghan SM, Fleming CA, Mohan HM, Harji D, Bolger JC, Elliott JA, Boland M, Lonergan PE, Dillon P, Quinlan DM, Winter DC. RETention of urine After INguinal hernia Elective Repair (RETAINER study I and II). Int J Surg Protoc. 2021 Apr 23;25(1):42-54. doi: 10.29337/ijsp.137.
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- Ceratti RDN, Beghetto MG. Incidence of urinary retention and relations between patient's complaint, physical examination, and bladder ultrasound. Rev Gaucha Enferm. 2021 Mar 12;42:e20200014. doi: 10.1590/1983-1447.2021.20200014. eCollection 2021. English, Portuguese.
- World Health Organization (WHO), Improving the Quality of Health Services: Tools and Resources, 2018. Available from: https://apps.who.int/iris/bitstream/handle/10665/310944/9789241515085-eng.pdf. 14 Aralık 2022.
- Akhtar A, Macfarlane RJ, Waseem M. Pre-operative assessment and post-operative care in elective shoulder surgery. Open Orthop J. 2013 Sep 6;7:316-22. doi: 10.2174/1874325001307010316. eCollection 2013.
- Official Gazette, Nursing Regulation, 2011. Number: 27910. https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.html . December 14, 2022
- Malley A, Kenner C, Kim T, Blakeney B. The role of the nurse and the preoperative assessment in patient transitions. AORN J. 2015 Aug;102(2):181.e1-9. doi: 10.1016/j.aorn.2015.06.004.
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- Urpo M, Eskola S, Suominen T, Roos M. (2021). Teamwork: a perspective of perioperative nurses. Central European Journal of Nursing and Midwifery, 12;430-440. doi:10.15452/cejnm.2021.12.0018.
- Yaban Simsek Z, Karaoz S. (2017). Effect of Nursing Interventions on Prevention and Management of Postoperative Urinary Retention for Patients with Orthopedic Surgery under Spinal Anaesthesia. International Journal of Caring Sciences, 10(1): 522-31.
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- Meska MH, Mazzo A, Jorge BM, Souza-Junior VD, Negri EC, Chayamiti EM. Urinary retention: implications of low-fidelity simulation training on the self-confidence of nurses. Rev Esc Enferm USP. 2016 Sep-Oct;50(5):831-837. doi: 10.1590/S0080-623420160000600017. English, Portuguese.
- Uslu Y, Yavuz M. (2016). Urinary retention and management after surgery. New Journal of Urology, 11 (1): 48-53.
- Afazel MR, Jalali E, Sadat Z, Mahmoodi H. Comparing the effects of hot pack and lukewarm-water-soaked gauze on postoperative urinary retention; a randomized controlled clinical trial. Nurs Midwifery Stud. 2014 Dec;3(4):e24606. doi: 10.17795/nmsjournal24606. Epub 2014 Dec 29.
- Dal U, Korucu AE, Eroglu K, Karatas B, Yalcin A. Sacral region massage as an alternative to the urinary catheter used to prevent urinary retention after cesarean delivery. Balkan Med J. 2013 Mar;30(1):58-63. doi: 10.5152/balkanmedj.2012.083. Epub 2013 Mar 1.
- Leach D, Spaulding J, Thomas J, Conn C, Kutash M. The effect of caffeine on postoperative urinary retention after joint replacement surgery. Orthop Nurs. 2013 Sep-Oct;32(5):282-5. doi: 10.1097/NOR.0b013e3182a30184.
- Zong J, You M, Li C. Effect of Kegel Pelvic Floor Muscle Exercise Combined with Clean Intermittent Self-catheterization on urinary retention after radical hysterectomy for cervical cancer. Pak J Med Sci. 2022 Mar-Apr;38(3Part-I):462-468. doi: 10.12669/pjms.38.3.4495.
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- Roudbari F. (2017). The effects of cold and hot compresses in the supra-pubic area on urinary retention in elderly patients after surgery. https://en.irct.ir/trial/19269. 13 Aralık 2022.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ankara Bilkent Sehir Hastanesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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