Evaluating Two Nursing Interventions to Prevent Urinary Retention After Spinal Anesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Suprapubic Cold Pack
Other interventionA 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.
Sacral Massage
Other interventionA 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.
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Suprapubic Cold Pack GroupExperimental treatment 1 intervention
Group B: Sacral Massage GroupExperimental treatment 1 intervention
Group C: Usual Care Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of participants who develop postoperative acute urinary retention
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).Secondary outcomes
1
Proportion of participants requiring urinary catheterization within the first 6 hours after surgery
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).2
Bladder-related discomfort or pain score within the first 6 hours after surgery
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).3
Time to first spontaneous voiding within the first 6 hours after surgery
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.
Time frame
Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: