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

Cairo University (CU)

Status: Completed

Conditions: Catheter Related Bladder Discomfort

Treatments: Drug: hyoscine-n-butylbromide; Drug: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03513250

bladder discomfort

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

hyoscine-n-butylbromide group

Experimental group

Description:

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.

Treatment:

Drug: hyoscine-n-butylbromide

control group

Placebo Comparator group

Description:

the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section.

Treatment:

Drug: control group