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临床试验/NCT00487084
NCT00487084已完成不适用

Interaction Between Epidural 2-chloroprocaine and Epidural Morphine: Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

Northwestern University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2004年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Duration of Continuing Analgesia

研究概览

简要总结

Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1). Several studies have hypothesized a specific opioid receptor mediated antagonism of chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due to a disparity between the time the chloroprocaine anesthesia resolves and the onset of epidural morphine analgesia, resulting in a time window of pain (2). The duration of action of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is 60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3). Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and morphine. There was no difference in postoperative analgesia between the two groups (3 and personal communication, Dr. Philip Hess). A literature search cross referencing epidural chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given before the procedure (in an attempt to time the onset of analgesia with the resolution of chloroprocaine anesthesia) to the standard administration time after the procedure.

详细描述

Women undergoing post partum tubal ligation with an epidural in-situ will be randomly double blindedly selected into one of three groups for pain control. The groups are epidural 1) epidural morphine-chloroprocaine 2) epidural chloroprocaine-morphine 3) epidural morphine-lidocaine. Groups 1 and 3 will receive morphine 30 minutes prior to local anesthetic dosing followed by saline placebo after local dosing. Group 2 will receive placebo 30 minutes prior to local anesthetic dosing followed by epidural morphine. Pain scores and supplemental analgesic requirements will be evaluated 30 minutes, 1hr, 2hr, 4hr and every 4 hrs for the first 24hrs.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients with an epidural catheter in situ for labor analgesia, status post a vaginal delivery, and scheduled for a postpartum tubal ligation under epidural anesthesia will be eligible

排除标准

  • Allergy/hypersensitivity to morphine
  • Allergy/hypersensitivity to ester-linked local anesthetics or para-amino benzoic acid (PABA)
  • Body Mass Index >40 kg/m2
  • Patients using chronic opioids
  • History of obstructive sleep apnea
  • Any contraindication to epidural anesthesia

研究组 & 干预措施

morphine - 2CP-saline (MCS)

Experimental

morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision

干预措施: Morphine-CP-saline (MCS) (Drug)

saline-2CP-morphine (SCM)

Experimental

saline will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level;morphine will be administered at skin incision

干预措施: saline-2CP-morphine (SCM) (Drug)

saline-lidocaine-morphine (SLM)

Active Comparator

Saline will be administered 30 min prior to epidural anesthesia; lidocaine will be used to achieve a T4 level; morphine will be administered at skin incision

干预措施: saline-lidocaine-morphine (SLM) (Drug)

结局指标

主要结局

Duration of Continuing Analgesia

时间窗: 48 hours

Time to first request for supplemental analgesia

Supplemental Analgesia in First 90 Minutes

时间窗: 90 min

Participants requesting supplemental analgesia in the first 90 minutes following study drug

次要结局

  • Verbal Rating Score (0 to 10) for Pain (VRPS)(At recovery room entry)
  • Supplemental Analgesia in First 48 Hours(48 hours)

研究者

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

Cynthia Wong

Professor of Anesthesiology

Northwestern University

研究点 (1)

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