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

Study Overview
=================
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.

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

Conditions
-----------------
Catheter Related Bladder Discomfort

Intervention / Treatment
-----------------
* Drug: hyoscine-n-butylbromide
* Drug: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyoscine-n-butylbromide group<br>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<br>* 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.<br>|
| Placebo Comparator: control group<br>the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section. | Drug: control group<br>* an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.<br>* Other names: saline group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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