Efficacy and Safety of Hyoscine-n-butylbromide for the Alleviation of Early Catheter-related Bladder Discomfort After Elective Cesarean Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.
排除标准
- •• 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.
研究组 & 干预措施
hyoscine-n-butylbromide group
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.
干预措施: hyoscine-n-butylbromide (Drug)
control group
the same volume (1 ml) of normal saline intravenously immediately before the end of the cesarean section.
干预措施: control group (Drug)
结局指标
主要结局
catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
时间窗: 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.
次要结局
- Postoperative nausea and vomiting(6 hours postoperative)
- catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).(six hours postoperatively.)
- facial flushing(6 hours postoperative)
- painkiller(Up to 6 hours after study drug administration)
- dry mouth(6 hours postoperative)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University