PUR: The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention

Sponsor

Ankara Yildirim Beyazıt University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05969145

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The development of postoperative urinary retention (PUR) is a significant complication in patients undergoing treatment due to orthopedic surgery. In particular, it is reported that the incidence rate of PUR after spinal anesthesia is in the range of 6-60%. It is stated in the literature that PUR can be prevented by reviewing factors such as bladder physical examination, fluid intake status, anesthesia type, bladder discharge time/condition of patients undergoing orthopedic surgery. For this purpose, our study showed that these patients had globular physical examination screening and postoperative 2-6. it aims to prevent postoperative urinary retention by applying hot and cold Decontamination to the bladders of patients who cannot urinate spontaneously between hours.

Condition or Disease	Intervention/Treatment	Phase
Hot-cold Application to the Bladder	Procedure: hot-cold application to the bladder	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a single-blind randomized controlled trial to determine the effect of hot-cold application to the bladder on postoperative urinary retention in orthopedic surgery patients.a single-blind randomized controlled trial to determine the effect of hot-cold application to the bladder on postoperative urinary retention in orthopedic surgery patients.

Masking:

Single (Participant)

Masking Description:

The participant will not know that there is a control or experimental group. The result evaluator is an independent statistical expert, and the data analysis will be performed by a statistical specialist.

Primary Purpose:

Health Services Research

Official Title:

The Effect of Hot-Cold Application to the Bladder After Orthopedic Surgery on Postoperative Urinary Retention

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Nov 15, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hot-cold application This group will be given a hot cold application to the bladder	Procedure: 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

Arm

Intervention/Treatment

Experimental: hot-cold application

This group will be given a hot cold application to the bladder

Procedure: 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

Outcome Measures

Primary Outcome Measures

physiological parameter, questionnaire [the first 6 hours of the postoperative period]
prevention of postoperative urinary retention by applying hot and cold to the bladder

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ankara Yildirim Beyazıt University

Investigators

Study Director: Gulay Yazici, Assoc. Dr.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Elif Demirden Erişti, Principal investigator, Ankara Yildirim Beyazıt University

ClinicalTrials.gov Identifier:

NCT05969145

Other Study ID Numbers:

Ankara Bilkent Sehir Hastanesi

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elif Demirden Erişti, Principal investigator, Ankara Yildirim Beyazıt University

orthopedic surgery

hot-cold application

postoperative urinary retention

Additional relevant MeSH terms:

Urinary Retention

Study Results

No Results Posted as of Aug 1, 2023