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Completed

NCT Number: NCT03513250

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

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.

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Key information

Conditions

Catheter Related Bladder Discomfort

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Ashour

Giza, 12944, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyoscine-N-butylbromide

Drug

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

Drug

an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.

Other names: saline group

Primary outcomes

  1. catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).

    Time frame: 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 outcomes

  1. catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).

    Time frame: two hours postopeatively.

    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").

  2. catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).

    Time frame: six hours postoperatively.

    numerical rating scale.

  3. Postoperative nausea and vomiting

    Time frame: 6 hours postoperative

    Postoperative nausea and vomiting

  4. dry mouth

    Time frame: 6 hours postoperative

    the patient says"My mouth is dry"

  5. facial flushing

    Time frame: 6 hours postoperative

    My face is hot.

  6. painkiller

    Time frame: Up to 6 hours after study drug administration

    the need for rescue analgesics

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 1, 2018
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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