THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Reducing of Catheter related bladder discomfort symptoms
研究概览
简要总结
The insertion of an urinary catheter in a patient undergoing a surgical procedure, especially in urinary interventions, may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with 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. Paracetamol is a drug with proven efficiency for the management of mild and moderate postoperative pain. In this study, the investigators hypothesized to address the effect of single-dose intravenous paracetamol on postoperative CRBD following percutaneous nephrolithotomy surgery (PNL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age,
- •American Society of Anesthesiologists (ASA) Physical Status of I-II,
- •undergoing PNL with urinary bladder catheter.
排除标准
- •obesity (BMI > 30),
- •chronic opioid use,
- •bladder outflow obstruction,
- •benign prostatic hyperplasia, and
- •overactive bladder (OAB) (frequency > 3 times at night or > 8 times within 24h).
研究组 & 干预措施
Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl
干预措施: Placebo (Drug)
Group Paracetamol(n=32):iv 15mg/kg paracetamol
The patients were randomly divided into two groups: Group P (Paracetamol group, n=32) received intravenous 15mg/kg paracetamol during the surgery and Group C (Control Group, n=32) received intravenous 1.5 ml/kg 0.9% NaCl solution 30 minutes before the of surgery.At the end of the surgery, all patients had an nephrostomy catheter and the insertion site was infiltrated with 20 ml 0.25% bupivacaine infiltration for postoperative analgesia. Each patient received patient-controlled intravenous analgesia by meperidine (10 mg bolus, 20-minute lock-out, no infusion dose and 4 hour limit) for postoperative analgesia. All patients were planned to receive tenoxicam 20 mg intravenously as a rescue analgesic when visual analogue scale (VAS) was >3.
干预措施: intravenous paracetamol (Drug)
结局指标
主要结局
Reducing of Catheter related bladder discomfort symptoms
时间窗: CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
次要结局
- Assessment of CRBD symptoms by the evaluation of VAS, sedation scales and hemodynamic findings(at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.)
研究者
Pinar Ergenoglu
Baskent University School of Medicine Adana Teaching and Research Hospital
Baskent University