Catheter Related Bladder Discomfort
Conditions
Brief summary
a prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.
Detailed description
The insertion of a urinary catheter in a patient undergoing a surgical procedure as cesarean section may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with an indwelling urinary catheter are similar to overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation with or without urge incontinence. Hyoscine N-butyl bromide also known as scopolamine is a drug with anticholinergic effects which exerts its effects by inhibiting the acetylcholine effects in parasympathetic receptors of smooth muscle cells, secretory glands, and central nervous system. Hyoscine-n-butylbromide was reported to be effective for treatment of CRBD. More preventive than therapeutic drugs for CRBD should be investigated to improve patient comfort in all surgery patients with a urinary catheter. A prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.
Interventions
one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section.
DRUGcontrol group
an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A prospective randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.
Exclusion criteria
* • Urinary infection (assessed clinically and by urinalysis of midstream sample of urine (MSSU) with chemical indicator strips or dipsticks). * Contraindications for general anesthesia. * Maternal bladder, urethral and renal disorders causing irritating voiding problems such as dysuria, urge and stress incontinence. * Obstructive voiding symptoms like incomplete emptying, straining and voiding difficulty before surgery. * Overactive bladder (frequency: more than three times during the night or more than eight times in 24 h). * Morbid obesity. * Disturbances of the central nervous system (epilepsy, patients receiving MAO inhibitor). * Hypertensive disorders and/ or systemic disease requiring particular patient care (for example, cardiac disease, nephritic disorders). * Chronic analgesic abuse. * Hepatic or psychiatric disease will be excluded from the study. * A history of hypersensitivity or contraindication to hyoscine-n-butylbromide.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS). | one hour post-operatively. | the incidence and severity of CRBD between the 2 groups will be assessed by the 11-point numerical rating scale which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). CRBD will be defined as the presence of an urge to void or suprapubic discomfort with an NRS score of ≥3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS). | two hours postopeatively. | the incidence and severity of CRBD between the 2 groups will be assessed by the 11-point numerical rating scale which is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). |
| Postoperative nausea and vomiting | 6 hours postoperative | Postoperative nausea and vomiting |
| dry mouth | 6 hours postoperative | the patient saysMy mouth is dry |
| facial flushing | 6 hours postoperative | My face is hot. |
| painkiller | Up to 6 hours after study drug administration | the need for rescue analgesics |
Countries
Egypt
Outcome results
None listed