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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00487084
First received: June 13, 2007
Last updated: March 17, 2014
Last verified: March 2014
  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
Labor
Analgesia, Epidural
Drug: Morphine-CP-saline (MCS)
Drug: saline-2CP-morphine (SCM)
Drug: saline-lidocaine-morphine (SLM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Duration of Continuing Analgesia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Time to first request for supplemental analgesia

  • Supplemental Analgesia in First 90 Minutes [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    Participants requesting supplemental analgesia in the first 90 minutes following study drug


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

  • Supplemental Analgesia in First 48 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Participants requesting supplemental analgesia in first 48 hours


Enrollment: 136
Study Start Date: August 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00487084     History of Changes
Other Study ID Numbers: 0524-021
Study First Received: June 13, 2007
Results First Received: February 9, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
analgesia
tubal ligation
chloroprocaine

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Chloroprocaine
Procaine
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics

ClinicalTrials.gov processed this record on August 28, 2014