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Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT00804609
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : March 7, 2016
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Brendan Carvalho, Stanford University

Study Description
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Brief Summary:
To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space.

Condition or disease Intervention/treatment Phase
Epidural Analgesia, Obstetric Drug: DepoDur following epidural lidocaine Drug: DepoDur following spinal anesthetic Not Applicable

Detailed Description:
To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space. Specifically, we are looking at pregnant women undergoing cesarean delivery who will be receiving these medications. A secondary objective is to evaluate how well DepoDur® works for pain control, as well as its safety, when it is given either alone or following a dose of epidural lidocaine.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effects of Epidural Lidocaine Administration on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® (Morphine Sulfate Extended-release Injection) in Patients Undergoing Cesarean Delivery
Study Start Date : September 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: DepoDur following epidural lidocaine
Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
 Drug: DepoDur following epidural lidocaine

All participant underwent cesarean delivery. An epidural "top-up" anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.

Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration.

Other Names:
  • DepoDur™
  • EREM (Extended Release Epidural Morphine)
Active Comparator: DepoDur following spinal anesthetic
Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
 Drug: DepoDur following spinal anesthetic

Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.

Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug.

Other Names:
  • DepoDur
  • EREM
  • extended release epidural morphine


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM) [ Time Frame: a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose ]
    The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria:

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general 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): NCT00804609


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Brendan Carvalho Stanford University
More Information
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Responsible Party: Brendan Carvalho, MD, Stanford University
ClinicalTrials.gov Identifier: NCT00804609    
Other Study ID Numbers: SU-07022008-1228
First Posted: December 9, 2008    Key Record Dates
Results First Posted: March 7, 2016
Last Update Posted: October 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lidocaine
Morphine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
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