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Two Dose Epidural Morphine for Post-cesarean Analgesia

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ClinicalTrials.gov Identifier: NCT01844206
Recruitment Status : Terminated (Slow recruitment of subjects)
First Posted : May 1, 2013
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Allison Lee, Columbia University

Study Description
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Brief Summary:
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Condition or disease Intervention/treatment Phase
Pain Morphine Adverse Reaction Drug: Epidural Morphine Drug: Epidural Saline Phase 4

Detailed Description:

This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Two Dose Epidural Morphine for Post-cesarean Analgesia
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Epidural Morphine
Group receiving 3mg epidural morphine, 24 hours after the initial dose
 Drug: Epidural Morphine
Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
Other Name: DepoDur
Placebo Comparator: Epidural Saline
Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
 Drug: Epidural Saline
Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Other Name: Sodium Chloride Solution


Outcome Measures
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Primary Outcome Measures :
  1. The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery [ Time Frame: Up to 48 hours post-operatively ]
    The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing cesarean section under epidural anesthesia.

Exclusion Criteria:

  • Emergent cesarean section
  • Coagulopathy
  • Failed epidural anesthesia or patchy block
  • General anesthesia
  • Use of epidural chloroprocaine
  • Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
  • Severe opioid side effects
  • History of chronic opioid use
  • History of chronic pain
  • History of obstructive sleep apnea
  • Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
  • Height under 4' 10" (147 cm)
  • Documented dural puncture by the epidural (Tuohy) needle
  • Preeclampsia
  • Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
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): NCT01844206


Locations
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United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Allison Lee, MD Columbia University
More Information
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Publications:

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Responsible Party: Allison Lee, Assistant Professor of Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT01844206    
Other Study ID Numbers: AAAL3857
First Posted: May 1, 2013    Key Record Dates
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015
Last Verified: November 2015
Keywords provided by Allison Lee, Columbia University:
Post-cesarean analgesia
Second dose of epidural morphine after surgery
Post-operative analgesia
Self-administered epidural morphine
Pain management after cesarean
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents