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

Not Applicable

Completed

• Conditions: Catheter Related Bladder Discomfort
• Interventions: Drug: hyoscine-n-butylbromide; Drug: control group

• Registration Number: NCT03513250
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-29
• Study First Posted: 2018-05-01
• Study Start: 2018-05-30
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyoscine-n-butylbromide group	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	control group	the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	6 hours postoperative	Postoperative nausea and vomiting
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).	six hours postoperatively.	numerical rating scale.
facial flushing	6 hours postoperative	My face is hot.
painkiller	Up to 6 hours after study drug administration	the need for rescue analgesics
dry mouth	6 hours postoperative	the patient says"My mouth is dry"

Trial Locations

Locations (1)

Ahmed Ashour; 🇪🇬 Giza, Egypt