Istanbul University-Cerrahpasa, Institute of Graduate Studies
Istanbul, Avcılar, 34320, Turkey (Türkiye)
NCT Number: NCT07293000
The goal of this clinical trial is to learn whether two simple nursing methods can help prevent trouble emptying the bladder (acute urinary retention, AUR) after surgery with numbing medicine in the lower back (spinal anesthesia). Adults having surgery in the scrotum (scrotal), groin (inguinal), pelvic area, lower belly (lower abdominal), or bones and joints (orthopedic surgery) with spinal anesthesia will take part. After surgery, participants will be randomly placed into one of three groups: one group will receive a cold pack on the lower belly (suprapubic area), a second group will receive a gentle massage on the lower back over the tailbone (sacral area), and a third group will receive usual care only with no extra procedure. The same nurse researcher will provide the study care for all groups, check how well participants pass urine, use a small painless scan on the lower belly to see how much urine is in the bladder (portable bladder ultrasound), and record whether a tube in the bladder to drain urine (urinary catheter) is needed.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Istanbul, Avcılar, 34320, Turkey (Türkiye)
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients who meet all of the following criteria will be included:
Exclusion criteria
Patients who meet any of the following criteria will be excluded:
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Hülya CEYHAN, RN, MSc
CONTACT
Yeliz ÇULHA, Associate Professor
CONTACT
Istanbul University - Cerrahpasa
Other
Evaluation of the Effectiveness of Two Different Nursing Interventions in Preventing Urinary Retention in Patients Undergoing Spinal Anesthesia: Randomized Controlled Trial
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