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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
92
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.
an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.
Ahmed Ashour
Giza, Egypt
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
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.
Time frame: one hour post-operatively.
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
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").
Time frame: two hours postopeatively.
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
numerical rating scale.
Time frame: six hours postoperatively.
Postoperative nausea and vomiting
Postoperative nausea and vomiting
Time frame: 6 hours postoperative
dry mouth
the patient says"My mouth is dry"
Time frame: 6 hours postoperative
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facial flushing
My face is hot.
Time frame: 6 hours postoperative
painkiller
the need for rescue analgesics
Time frame: Up to 6 hours after study drug administration