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| Sponsor: | Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00487084 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Labour Analgesia, Epidural |
Drug: chloroprocaine,morphine, lidocaine administration |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Interaction Between Epidural 2-Chloroprocaine and Epidural Morphine: Effect of Timing on Efficacy of Morphine Analgesia After 2-Chloroprocaine Anesthesia |
| Estimated Enrollment: | 129 |
| Study Start Date: | August 2004 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Women undergoing post partum tubal ligation with an epidural in-situ will be randomly double blindedly selected into one of four groups for pain control. The groups are epidural 1) epidural morphine-choroprocaine 2) epidural chloroprocaine-morphine 3) epidural morphine-lidocaine 4) epidural lidocaine-morphine. Groups 1 and 3 will receive morphine 30 minutes prior to local anesthetic dosing followed by saline placebo after local dosing. Groups 2 and 4 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Cynthia A Wong, M.D. | Northwestern University |
More Information
| Responsible Party: | Northwestern University ( Cynthia A. Wong, M.D. ) |
| Study ID Numbers: | 0524-021 |
| Study First Received: | June 13, 2007 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00487084 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
analgesia tubal ligation chloroprocaine |
|
Morphine Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Procaine Narcotics Anesthetics, Local Pharmacologic Actions |
Chloroprocaine Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |