Efficacy and Safety of Hyoscine-n-butylbromide for the Alleviation of Early Catheter-related Bladder Discomfort After Elective Cesarean Delivery: a Randomized Controlled Trial
Sponsor study identifier
interventional
92
1 country
1
Study Start
May 30, 2018
Actual (reported)Primary Completion
July 1, 2020
Actual (reported)Study Completion
July 15, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 10, 2018
Actual (reported)May 1, 2018
Actual (reported)May 30, 2018
Actual (reported)July 1, 2020
Actual (reported)July 15, 2020
Actual (reported)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.
one hour post-operatively.
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
two hours postopeatively.
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
six hours postoperatively.
Postoperative nausea and vomiting
6 hours postoperative
dry mouth
6 hours postoperative
facial flushing
6 hours postoperative
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.
the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section.
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, 12944, Egypt
AHMED SAMY, MD
Cairo University
92 participants (actual enrollment reported by the registry).
First Submitted
April 10, 2018
First Posted
May 1, 2018
Study Start
May 30, 2018
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2020
Actual (reported)Study Completion
July 15, 2020
Actual (reported)Last Updated
January 13, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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