Do Women Receiving Low Dose Combined Spinal Epidural for Labor Analgesia Exhibit Less Bacteriuria Using a Urinary Retention Protocol Versus Routine Urinary Catheter Placement?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Number of Participants With Positive Urine Culture
研究概览
简要总结
The investigators hypothesize that many parturients can, in fact, spontaneously micturate with low dose combined spinal epidural analgesic doses given for labor and that Foley catheterization is unnecessary in the majority of these parturients. At Prentice Women's Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those receive Foley catheters. By potentially reducing the necessity for Foley catheters, the investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract infections and urethritis leading to unnecessary treatment with antibiotics, as well as reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving low dose combined spinal epidural analgesia for analgesia after induction of labor who are randomized to a spontaneous micturition protocol will require fewer Foley catheter placements and demonstrate a lower incidence of positive urine culture postpartum than those who undergo standard Foley catheter placement.
详细描述
Participation in the study will begin at the patient's request for labor analgesia. The patient will be asked to urinate and a post void residual (PVR) will be measured via ultrasonography. If the PVR is >100mL, the patient will be excluded from the study. If CSF is not obtained during CSE placement or the CSE technique is abandoned for any other reason, the patient will be excluded. If the PVR is < 100mL and the combined spinal epidural analgesia is successful, they will be randomized to receive either routine Foley catheter placement or begin the spontaneous micturition protocol. Last cervical exam and VRS pain will be recorded at this time.
Subjects will be prepared in the usual fashion for the combined spinal epidural with hemodynamic monitoring and intravenous (IV) access.
The anesthesiologist will perform a combined spinal epidural analgesia per routine with the subject in the sitting position using sterile technique at the L3-4 interspace (± one vertebral interspace). The epidural space will be found using loss of resistance technique with either 3 mL of air or saline and a 17G Touhy needle. After the epidural space is identified, the dura will be punctured with a 27G Pencan and 2.5mg of plain bupivacaine + 15 μg fentanyl will be injected. The epidural catheter will be inserted to 3-5cm into the epidural space and a test dose of 3 mL of 1.5% lidocaine + 1:200,000 epinephrine will be injected. The epidural catheter will be secured and the PCEA initiated with the standard infusion rate and patient administered boluses using 0.06% bupivacaine + 2mcg/mL fentanyl. Post-procedure vital signs will be monitored in the usual fashion.
Patients randomized to the control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Their bladder volume will be assessed via ultrasonography before Foley catheter placement. The volume of urine collected in the Foley bag will be used to validate our ultrasonographic measurements.
Patients randomized to the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. First, the patient's bladder volume is measured via ultrasonography; this is followed by an attempt at spontaneous micturition. The patient will have an attempt at spontaneous micturition only if their bladder contains >100mL of urine. This ensures inability to micturate is not due to insufficient urine in the bladder prior to their attempt. An ultrasonographic measurement of their postvoid residual volume will follow their attempt to spontaneously micturate, to ensure the patient does not have urinary retention necessitating Foley catheter placement.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous
- •Term (≥37 week gestation)
- •ASA class 1-2
- •Who are being induced for labor who request labor analgesia and who successfully receive standard combined spinal epidural analgesia (verbal rating score for pain ≤ 1 after 10 min)
排除标准
- •Women with ASA 3 or greater
- •BMI ≥40 kg/m2
- •Prior history of urge or stress incontinence or urinary retention before pregnancy
- •Women with a history of nephrolithiasis
- •Chronic urinary tract infections
- •Women whose post-void residual volume as assessed by ultrasonography is found to be >100ml before epidural placement will be excluded.
- •Women with an absolute or relative contraindication to the usual combined spinal epidural technique
- •Failed analgesia will be excluded
- •Women for whom the anesthesiologist selects an analgesic technique other than combined spinal epidural technique or fail to obtain CSF for CSE will be excluded
- •Women with fetal heart rate decelerations before request for analgesia will be excluded due to increased risk of cesarean delivery.
- •Women who experience inadequate labor analgesia due to nonfunctioning epidural catheter necessitating epidural replacement will be included but noted as a protocol violation.
研究组 & 干预措施
Foley catheter
Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution.
干预措施: Foley catheter (Device)
No Foley Catheter
Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
干预措施: No foley catheter (Other)
结局指标
主要结局
Number of Participants With Positive Urine Culture
时间窗: 48 Hours
This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection.
次要结局
未报告次要终点