- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293000
Evaluating Two Nursing Interventions to Prevent Urinary Retention After Spinal Anesthesia
Evaluation of the Effectiveness of Two Different Nursing Interventions in Preventing Urinary Retention in Patients Undergoing Spinal Anesthesia: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trouble emptying the bladder after surgery (acute urinary retention, AUR) is a common and important problem in adults who receive numbing medicine in the lower back (spinal anesthesia). AUR can cause pain, an overfilled bladder (bladder distension), urinary tract infection, longer hospital stays, and higher health care costs. The usual way to manage AUR is to place a tube into the bladder to drain urine (urinary catheterization). This works, but it is invasive and may lead to infection, injury to the urethra, and discomfort. Because of these risks, there is a need for simple, non-drug, non-invasive nursing methods to help prevent AUR.
Spinal anesthesia can temporarily block normal bladder function and increase the risk of AUR. Nurses are often the first to notice when a person is unable to pass urine and are in a key position to provide early, preventive care. Some studies have looked at different nursing interventions for urinary retention, but there is little evidence about non-invasive methods after spinal anesthesia, and no trial has directly compared a cold pack on the lower belly with a massage over the tailbone in this setting.
This randomized controlled trial will include adult surgical patients who receive spinal anesthesia for operations in the scrotum (scrotal), groin (inguinal), pelvic area, lower belly (lower abdominal), or bones and joints (orthopedic surgery). Participants will be randomly assigned to one of three groups:
- a dry cold pack applied to the lower belly over the bladder (suprapubic area),
- gentle massage over the lower back in the area of the tailbone (sacral area), or
- usual postoperative care without an extra study procedure.
All study procedures in all three groups will be carried out by a single nurse researcher, using the same assessment steps for every participant. The aim is to keep the care consistent and reduce differences that are not related to the study methods.
The main focus of the study is to find out whether these nursing methods can lower the rate of acute urinary retention after spinal anesthesia. Nurses will regularly check how well participants can pass urine on their own and will estimate bladder volume using a small, painless scan placed on the skin over the lower belly (portable bladder ultrasound device). This objective measurement is expected to improve early detection of AUR compared with relying only on symptoms or physical examination.
The study will also look at related outcomes such as time to first spontaneous urination, need for urinary catheterization, bladder fullness and pain, and comfort and satisfaction with nursing care. By providing clear, comparative information on two simple, non-invasive nursing interventions, this trial aims to support evidence-based postoperative nursing protocols, improve patient comfort, and reduce the need for invasive urinary catheterization after spinal anesthesia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hülya CEYHAN, RN, MSc
- Phone Number: +90 545 541 40 29
- Email: hulya.ceyhan@ogr.iuc.edu.tr
Study Contact Backup
- Name: Yeliz ÇULHA, Associate Professor
- Phone Number: +90 544 284 50 80
- Email: yeliz.culha@iuc.edu.tr
Study Locations
-
-
Avcılar
-
Istanbul, Avcılar, Turkey (Türkiye), 34320
- Istanbul University-Cerrahpasa, Institute of Graduate Studies
-
Contact:
- Hülya CEYHAN, RN,MSc
- Phone Number: +90 545 541 40 29
- Email: hulya.ceyhan@ogr.iuc.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Patients who meet all of the following criteria will be included:
- Age 18 years or older
- No diagnosis of urolithiasis, benign prostatic hyperplasia, neurogenic bladder, cancer, or other malignancy
- No diagnosis of urinary tract infection within the last month
- No history of prior urological surgery or surgery involving the sacral region
- No history of urinary retention
- Not using antidepressants, antipsychotics, muscarinic receptor antagonists, alpha-blockers, or similar medications
- No contraindication for applying cold to the suprapubic area or massage to the sacral area (e.g., no pacemaker, bladder stimulator, or other sensitive electronic medical device in the sacral region)
- No visual, hearing, cognitive, or perceptual impairment
Exclusion Criteria:Patients who meet any of the following criteria will be excluded:
- Duration of surgery longer than 2 hours
- Urinary catheterization performed preoperatively, intraoperatively, or postoperatively
- Blood transfusion performed preoperatively, intraoperatively, or postoperatively
- Development of complications such as hypothermia, bleeding, or other conditions that prevent the application of dry cold or sacral massage in the preoperative, intraoperative, or postoperative period
- Transfer to the intensive care unit after surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Suprapubic Cold Pack Group
Participants in this arm receive a suprapubic dry cold pack in addition to usual postoperative nursing care after surgery with spinal anesthesia.
The cold pack is applied in the early postoperative period according to a standard nursing protocol.
|
A dry cold pack applied externally to the skin over the lower abdomen above the bladder (suprapubic area) in adult patients after surgery with spinal anesthesia.
The cold pack is used for a predefined duration in the early postoperative period as a non-pharmacologic, non-invasive nursing intervention to support bladder emptying and patient comfort.
|
|
Experimental: Sacral Massage Group
Participants in this arm receive sacral massage in addition to usual postoperative nursing care after surgery with spinal anesthesia.
The massage is delivered in the early postoperative period by a nurse researcher following a standard nursing protocol.
|
A gentle manual massage applied externally to the skin over the lower back in the sacral (tailbone) region in adult patients after surgery with spinal anesthesia.
The massage is performed for a predefined duration in the early postoperative period as a non-pharmacologic, non-invasive nursing intervention to support bladder function and patient comfort.
|
|
No Intervention: Usual Care Control Group
Participants in this arm receive only usual postoperative nursing care after surgery with spinal anesthesia, according to the hospital's standard protocols.
They do not receive any additional study-specific intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants who develop postoperative acute urinary retention
Time Frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
Proportion of participants who develop postoperative acute urinary retention (AUR) within the first 6 hours after surgery with spinal anesthesia, defined as inability to void spontaneously requiring urinary catheterization and/or elevated bladder volume on bladder ultrasound.
|
Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants requiring urinary catheterization within the first 6 hours after surgery
Time Frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
Proportion of participants requiring insertion of a urinary catheter within the first 6 hours after surgery with spinal anesthesia because of inability to void spontaneously or clinically significant bladder distension.
|
Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
|
Bladder-related discomfort or pain score within the first 6 hours after surgery
Time Frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
Bladder-related discomfort or pain score assessed within the first 6 hours after surgery with spinal anesthesia using a numerical rating scale from 0 to 10, with higher scores indicating greater discomfort or pain.
|
Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
|
Time to first spontaneous voiding within the first 6 hours after surgery
Time Frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
Time to first spontaneous voiding within the first 6 hours after surgery with spinal anesthesia, measured in minutes from the end of surgery to the first spontaneous voiding without urinary catheterization.
|
Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCEYHAN
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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