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

NCT03513250 | Completed

• 1 other identifier: bladder discomfort
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Related Bladder Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

hyoscine-n-butylbromide group

EXPERIMENTAL

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.

Drug: hyoscine-n-butylbromide

control group

PLACEBO COMPARATOR

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

Drug: control group

Interventions

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.

hyoscine-n-butylbromide group

control group DRUG

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

Also known as: saline group

control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Ashour

Giza, 12944, Egypt

Location

MeSH Terms

Interventions

Butylscopolammonium Bromide; Control Groups

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Model Details: A prospective randomized clinical trial

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 1, 2018
• Study Start: May 30, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 15, 2020
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

EG (1)