The Maternal CLIMB Trial: Chloroprocaine to Reduce the Impact of Motor Block on Patient Recovery After Short Obstetric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Motor block-interval assessment
研究概览
简要总结
The following obstetric procedures are commonly performed with spinal anesthesia on labor and delivery: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, and evacuation of retained products of conception. Bupivacaine is currently the standard spinal medication for these procedures because of its long history of safe use, its low incidence of transient neurologic symptoms, and its ability to provide a dependable, dense block with a high degree of maternal satisfaction. While bupivacaine has the aforementioned advantages, it unfortunately has a long duration of action, up to 240-380 minutes, which far exceeds the time necessary to complete most obstetric procedures. Clorotekal®, the first Food and Drug Administration approved chloroprocaine solution created for spinal injection, is a potential alternative. When compared with bupivacaine spinals, chloroprocaine spinals have been shown to facilitate clinically significant shorter times to resolution of motor and sensory block, first ambulation, micturition, and discharge readiness. The objective of this study is to determine if a strategy of spinal anesthesia with chloroprocaine will reduce the duration of motor block, compared with equivalent block with hyperbaric bupivacaine..
详细描述
This will be a single-blind, randomized, controlled, single center clinical trial assessing the efficacy of spinal chloroprocaine on resolution of motor block and associated patient flow through the post-anesthesia care unit . Fifty patients will be equally randomized to receive either spinal chloroprocaine or hyperbaric bupivacaine.
Masking:
- Subject
- Obstetric provider
- Investigator
- Outcomes assessor
The anesthesia provider will be unblinded.
Subjects will be allocated to either intrathecal injection of 50 mg of 1% chloroprocaine or 10.5 mg (1.4 mL) of 0.75% hyperbaric bupivacaine. The intrathecal space will be accessed with a 25 gauge Whitacre needle. Upon obtaining cerebrospinal fluid, the syringe of study solution will be attached the end of the Whitacre needle. The syringe will be pulled back to reveal aspiration of cerebrospinal fluid. The study solution will then be administered over approximately 5 seconds. The Whitacre needle and spinal introducer needle will be removed from the patient's back. The patient will be placed supine on the operating room table. The outcomes assessor will then be allowed to enter the operating room.
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)
盲法说明
The subject, obstetrical provider, investigator, and outcomes assessor will be blinded. The anesthesia provider will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18 years old to 60 years old
- •American Society of Anesthesiologists physical status class 1-3
- •Undergoing one of the following obstetric procedures: bilateral tubal ligation, external cephalic version, cerclage insertion, cerclage removal, minimally invasive fetal surgery, or evacuation of retained products of conception.
排除标准
- •Refusal of consent
- •Multiple gestations
- •History of ester local anesthetic or para-aminobenzoic acid allergy
- •Height less than 5 feet or greater than 6 feet
- •Body mass index less than 18.5 kg/m2 or greater than 45 kg/m2
- •Any coagulopathy defined by platelets < 80k/microliter, International Normalized Ratio > 1.2, or Partial Thromboplastin Time > 36 seconds
- •Signs of hypovolemia that is not corrected by routine management including hypotension (systolic blood pressure < 90 mm Hg) at the time of evaluation
- •Liver disease including jaundice and ascites, with elevated liver function tests, Aspartate Aminotransferase > 2x institutional normal, Alanine Aminotransferase > 2x institutional normal
- •Renal disease including history of dialysis, with elevated renal function tests on admission labs, glomerular filtration rate < 60 ml/min/1.73 m2
- •Infection at the site of potential spinal insertion
- •Neurologic condition that contraindicates spinal anesthesia, tethered spinal cord or multiple sclerosis
- •Known atypical plasma cholinesterase activity
- •Other contraindications to receive a spinal anesthetic
- •Vulnerable populations including prisoners and decisionally impaired adults
研究组 & 干预措施
Chloroprocaine
50 mg of 1% spinal chloroprocaine (5 mL) injected into the intrathecal space over approximately 5 seconds once prior to the start of surgery
干预措施: Chloroprocaine Injection [Clorotekal] (Drug)
Bupivacaine
10.5 mg of spinal hyperbaric bupivacaine (1.4 mL of 0.75% bupivacaine hydrochloride in 8.25% dextrose) injected into the intrathecal space over approximately 5 seconds once prior to the start of surgery
干预措施: Bupivacaine Hydrochloride 0.75% Injection Solution (Drug)
结局指标
主要结局
Motor block-interval assessment
时间窗: 5 hours
Bromage scale score at 5 minute intervals, since spinal injection. Interval assessment motor block will be defined as the number of 5-minute intervals since completion of spinal injection to achieve a Bromage score or 2 (able to flex knees)
次要结局
- Bladder Catheterization(24 hours)
- Post-Anesthesia Care Unit time (Phase 1 + Phase 2)(12 hours)
- Motor block-patient report(5 hours)
- Phase 1 Post-Anesthesia Care Unit time(8 hours)
- Time to ambulation(24 hours)
研究者
Brandon M Togioka
Principal Investigator
Oregon Health and Science University