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Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation

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ClinicalTrials.gov Identifier: NCT03103100
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Mark Powell, University of Alabama at Birmingham

Brief Summary:
This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: 1% Lidocaine Drug: 0.25% Bupivacaine Drug: Bupivacaine plus Lidocaine Phase 3

Detailed Description:

The most common and effective method for controlling labor pains is a local anesthetic (LA) infusion through a lumbar epidural. To achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10 dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering LA through the epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. The ideal LA to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects.

Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these LA can be administered safely with very little concern of major adverse effects associated with LA toxicity. Given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the LA combination offers any distinct advantage over the individual LA. The investigators intend to determine the time it takes to achieve an adequate level (T10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal LA solution to activate a labor epidural. With the results from this study, the investigators hope to recommend a LA solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study
Actual Study Start Date : October 8, 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1% Lidocaine
Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine
Drug: 1% Lidocaine
10 mL of 1% lidocaine
Other Names:
  • Lidoderm, Xylocaine, Recticare, Anecream,
  • Solarcaine, Anestacon, Cutiecaine, Lidocoll,

Active Comparator: 0.25% Bupivacaine
Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine
Drug: 0.25% Bupivacaine
10 mL of 0.25% bupivacaine
Other Name: Marcaine and Sensorcaine

Active Comparator: Bupivacaine plus Lidocaine
Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.
Drug: Bupivacaine plus Lidocaine
5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Other Names:
  • Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,
  • Marcaine and Sensorcaine




Primary Outcome Measures :
  1. Time to achieve an adequate epidural level for labor analgesia [ Time Frame: Baseline to 1 hour ]
    time it takes to achieve a T10 dermatome level by pinprick


Secondary Outcome Measures :
  1. Total Spread [ Time Frame: Baseline to 1 hour ]
    the total spread (both cephalad and caudal) of the LA (dermatome level to be determined by pin prick and ice),

  2. Degree of motor block [ Time Frame: Baseline to 1 hour ]
    onset and degree of motor block

  3. Incidence of maternal hypotension [ Time Frame: Baseline to 1 hour ]
    incidence of maternal hypotension defined as a BP >20% decline from baseline and need for vasopressor therapy

  4. Change in fetal status [ Time Frame: Baseline to 1 hour ]
    any change in fetal status by monitoring FHR.



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy females admitted for induction of labor
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study

Exclusion Criteria:

  • age <19
  • allergy to the drug or drug class
  • preexisting neuropathy
  • history of back pain prior to pregnancy or history of back surgery
  • history of chronic opioid use
  • history of hypertension or hypertensive disorders of pregnancy
  • congenital or acquired cardiac disease
  • contraindication to epidural placement (patient refusal, severe coagulopathy, infection at site of epidural needle insertion, severe hypovolemia)

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): NCT03103100


Contacts
Contact: Alicia Kindred, MS 205-934-4711 aliciakindred@uabmc.edu
Contact: Ayesha Bryant, MD 205-996-7383 asbryant@uabmc.edu

Locations
United States, Alabama
UAB Department of Anesthesiology and Perioperative Medicine Recruiting
Birmingham, Alabama, United States, 35249
Contact: Adam Sturdivant, MPH    205-934-4042    adamsturdivant@uabmc.edu   
Contact: Ayesha Bryant, MSPH, MD    205-996-7383    asbryant@uabmc.edu   
Principal Investigator: Mark Powell, MD         
Sub-Investigator: Michael Froelich, MD         
Sub-Investigator: Promil Kukreja, MD, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Mark F Powell, MD University of Alabama at Birmingham

Responsible Party: Mark Powell, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03103100     History of Changes
Other Study ID Numbers: F140903008
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mark Powell, University of Alabama at Birmingham:
Local anesthetic
Labor epidural

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
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