Efficacy of Hyoscine-n-butylbromide in Catheter-related Bladder Discomfort After Elective Cesarean Section.

Catheter Related Bladder Discomfort Clinical Trial

Official title:

Efficacy and Safety of Hyoscine-n-butylbromide for the Alleviation of Early Catheter-related Bladder Discomfort After Elective Cesarean Delivery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513250
• Other study ID #: bladder discomfort
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: January 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 15, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 dif?culty 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.

Related Conditions & MeSH terms

• Catheter Related Bladder Discomfort

Intervention

Drug:
• hyoscine-n-butylbromide
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.
• control group
an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.

Locations

Country	Name	City	State
Egypt	Ahmed Ashour	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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").	two hours postopeatively.
Secondary	catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).	numerical rating scale.	six hours postoperatively.
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting	6 hours postoperative
Secondary	dry mouth	the patient says"My mouth is dry"	6 hours postoperative
Secondary	facial flushing	My face is hot.	6 hours postoperative
Secondary	painkiller	the need for rescue analgesics	Up to 6 hours after study drug administration