Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Lower Urinary Tract Function: A Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Post void residual urine volume: Change between postvoid residual urine volume before surgery versus during thoracic epidural analgesia for postoperative analgesia
研究概览
简要总结
Acute urinary retention is one of the most common complications after surgery and anesthesia. Micturition depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Under the influence of epidural analgesia, patients may not feel the sensation of bladder filling, which can result in urinary retention and bladder overdistension. Overfilling of the bladder can stretch and in some cases permanently damage the detrusor muscle. Because epidural anesthesia can be performed at various levels of the spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade). Thoracic epidural analgesia with bupivacaine significantly inhibits the detrusor muscle during voiding, resulting in clinically relevant post void residuals which required monitoring or transurethral catheterisation. This bladder muscle inhibition is comparable to a motor blockade. The epidural administration of ropivacaine during labour results in a clinically relevant reduction of motor blocks.
The hypothesis is that thoracic epidural analgesia with the local anesthetics ropivacaine leads to less significant changes in bladder function than bupivacaine as a control group, in patients undergoing lumbotomy incision for renal surgery.
详细描述
Background
Acute urinary retention is one of the most common complications after surgery and anesthesia. It can occur in patients of both sexes and all age groups and after all types of surgical procedures. It is linked to several factors including increased intravenous fluids, postoperative pain and type of anaesthesia.
Micturition depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Motorneurons of both muscles are located in the sacral spinal cord and coordination between them occurs in the pontine tegmentum of the caudal brain stem. Motorneurons innervating the external urethral sphincter are located in the nucleus of Onuf, extending from segment S1 to S3. The detrusor smooth muscle is innervated by parasympathetic fibers, which reside in the sacral intermediolateral cell group and are located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important role in promoting continence and are located in the intermediolateral cell group of the lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated.
There are few studies on the urodynamic effects of various anaesthetic agents, which mainly focused on lumbar epidural anaesthesia. Under the influence of epidural analgesia, patients may not feel the sensation of bladder filling, which can result in urinary retention and bladder overdistension. Overfilling of the bladder can stretch and in some cases permanently damage the detrusor muscle.
Because epidural anesthesia can be performed at various levels of the spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade). Based on knowledge of the bladder innervations, it can be assumed that epidural analgesia within segments T4-6 to T10-12 has no or minimal influences on lower urinary tract function.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Kidney surgery
- •Thoracic epidural analgesia
- •Exclusion Criteria
- •Contraindications to epidural analgesia or refusal
- •Preoperative postvoid residual urine volume > 100ml
- •International Prostate Symptom Score (IPSS) > 7
- •Pregnancy (pregnancy test in all women who are not in menopause, exclusion for surgery per se)
排除标准
- 未提供
研究组 & 干预措施
Ropivacaine
Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
干预措施: Ropivacaine 2mg/ml (Drug)
Bupivacaine
Bupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz)
干预措施: Bupivacaine (Drug)
Ropivacaine
Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
干预措施: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland) (Device)
Ropivacaine
Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
干预措施: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland) (Device)
Bupivacaine
Bupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz)
干预措施: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland) (Device)
Bupivacaine
Bupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz)
干预措施: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland) (Device)
结局指标
主要结局
Post void residual urine volume: Change between postvoid residual urine volume before surgery versus during thoracic epidural analgesia for postoperative analgesia
时间窗: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
次要结局
- Bladder volume at first desire to void (mL)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))
- Maximum cystometric capacity (mL)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))
- Urethral pressure profile (cmH2O)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))
- Bladder compliance (mL/cmH2O)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))
- Maximum detrusor pressure (cmH2O)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))
- Detrusor pressure at maximum flow rate(cmH2O)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))
- Maximum flow rate (mL/sec)(before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days))