跳至主要内容
临床试验/NCT02862912
NCT02862912已完成4 期

Chloroprocaine Versus Bupivacaine Spinal Anesthesia for Cervical Cerclage

Columbia University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2016年11月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
43
试验地点
1
主要终点
Time to Resolution of Motor Block

研究概览

简要总结

This study aims to determine whether or not spinal anesthesia with the local anesthetic drug, chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in faster discharge from the post-anesthesia care unit after surgery.

详细描述

This will be a prospective, randomized, double blind clinical trial. Subjects will be ASA I and II women ≥18 yrs old with a singleton pregnancy in the 1st or 2nd trimester of pregnancy undergoing cervical cerclage with spinal anesthesia. Patients will be randomly allocated to the chloroprocaine (CP) or bupivacaine group (BUP). Patients will receive spinal anesthesia with either chloroprocaine 50 mg with fentanyl 15 mcg or bupivacaine 9 mg with fentanyl 15 mcg.

Bupivacaine is the most common local anesthetic used for cervical cerclage with spinal anesthesia. Bupivacaine is safe and has been preferred over other medications such as lidocaine, because it is associated with a low incidence of a complication from spinal anesthesia known as "transient neurologic symptoms" - a condition where pain and cramping in the buttocks and lower extremities can be experienced for several days. Bupivacaine is a long-acting local anesthetic agent and therefore has the disadvantage of a prolonged anesthetic recovery that may last a few hours.

Chloroprocaine is a local anesthetic with a fast onset and short duration that may be used for spinal anesthesia for ambulatory procedures. Chloroprocaine is currently used at the research institution for spinal anesthesia for ambulatory surgical patients, especially for lower extremity orthopedic procedures such as knee arthroscopy, as well as for pregnant patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • ASA I and II women
  • 18-45 yrs old
  • Singleton pregnancy
  • Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia
  • Height 150 - 180 cm
  • BMI ≤ 40 kg/m2.

排除标准

  • Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g., multiple sclerosis, spinal stenosis, central or peripheral neuropathy)
  • Pre-existing/chronic back pain
  • Ester local anesthetic allergy, PABA allergy
  • History of atypical cholinesterase (CP is metabolized by cholinesterase)

研究组 & 干预措施

Chloroprocaine (CP)

Experimental

Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)

干预措施: Chloroprocaine (Drug)

Chloroprocaine (CP)

Experimental

Patients in CP group will receive 3% 2-chloroprocaine 50 mg (1.67 ml) and fentanyl 15 mcg (0.3 ml)

干预措施: Fentanyl (Drug)

Bupivacaine (BUP)

Active Comparator

Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml

干预措施: Bupivacaine (Drug)

Bupivacaine (BUP)

Active Comparator

Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml

干预措施: Fentanyl (Drug)

Bupivacaine (BUP)

Active Comparator

Patients in BUP group will receive hyperbaric 0.75% bupivacaine 9 mg (1.4 ml), with fentanyl 15 mcg (0.3 ml), with saline (0.3 ml) to bring the volume to ~ 2 ml

干预措施: Saline (Drug)

结局指标

主要结局

Time to Resolution of Motor Block

时间窗: 3 hours

The mean difference between groups in time between the end of spinal injection (t IT) to time for no motor block (t motor), i.e. tIT - T motor. Motor block will be assessed using the Bromage scale: Bromage Scale I = free movement of the legs and feet = no block II = able to flex knees, with free movement of feet = partial (33%) block III = unable to flex knees, but with free movement of the feet = almost complete (66%) block IV = unable to move legs or feet = complete block (100%)

次要结局

  • Time to Ambulate(5 hours)
  • Time to Void(5 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard M. Smiley

Professor of Anesthesiology

Columbia University

研究点 (1)

Loading locations...

相似试验

Chloroprocaine Spinal Anesthesia for Cervical... | 临床试验