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Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia

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ClinicalTrials.gov Identifier: NCT00487084
Recruitment Status : Completed
First Posted : June 15, 2007
Results First Posted : April 18, 2011
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Labor Analgesia, Epidural Drug: Morphine-CP-saline (MCS) Drug: saline-2CP-morphine (SCM) Drug: saline-lidocaine-morphine (SLM) Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interaction Between Epidural 2-chloroprocaine and Epidural Morphine: Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia
Study Start Date : August 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arms and Interventions
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Arm Intervention/treatment
Experimental: morphine - 2CP-saline (MCS)
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
 Drug: Morphine-CP-saline (MCS)
3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision
Experimental: saline-2CP-morphine (SCM)
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
 Drug: saline-2CP-morphine (SCM)
6ml of saline will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 3mg of preservative free morphine will be administered at skin incision
Active Comparator: saline-lidocaine-morphine (SLM)
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
 Drug: saline-lidocaine-morphine (SLM)
3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 2% lidocaine with epinephrine 1:200,000 will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision


Outcome Measures
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Primary Outcome Measures :
  1. Duration of Continuing Analgesia [ Time Frame: 48 hours ]
    Time to first request for supplemental analgesia

  2. Supplemental Analgesia in First 90 Minutes [ Time Frame: 90 min ]
    Participants requesting supplemental analgesia in the first 90 minutes following study drug


Secondary Outcome Measures :
  1. Verbal Rating Score (0 to 10) for Pain (VRPS) [ Time Frame: At recovery room entry ]
    Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable

  2. Supplemental Analgesia in First 48 Hours [ Time Frame: 48 hours ]
    Participants requesting supplemental analgesia in first 48 hours


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487084


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Cynthia A Wong, M.D. Northwestern University
More Information
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Publications:

Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00487084     History of Changes
Other Study ID Numbers: 0524-021
First Posted: June 15, 2007    Key Record Dates
Results First Posted: April 18, 2011
Last Update Posted: April 14, 2014
Last Verified: March 2014

Keywords provided by Cynthia Wong, Northwestern University:
analgesia
tubal ligation
chloroprocaine

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Lidocaine
Chloroprocaine
Procaine
Morphine
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics