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

• ClinicalTrials.gov Identifier: NCT03103100
• Recruitment Status: Completed
• First Posted: April 6, 2017
• Results First Posted: August 31, 2020
• Last Update Posted: August 31, 2020
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Mark Powell, University of Alabama at Birmingham

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 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
• Actual Primary Completion Date: July 1, 2019
• Actual Study Completion Date: September 9, 2019

Arms and Interventions

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

Outcome Measures

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. A T10 dermatome level is what is needed to control labor pain.

Secondary Outcome Measures :

1. Number of Patients Who Achieve Adequate Analgesia [ Time Frame: Baseline to 1 hour ]
   The number of patients who received an adequate epidural level of T10 or higher
2. Degree of Motor Block [ Time Frame: Baseline to 1 hour ]
   degree of motor block which means the amount of weakness in the legs experienced by the participants. this was determined by using the Bromage scale where 4 = greatest amount of motor block or muscle weakness and 0 = the least amount of motor block.
3. Number of Patients Who Experienced of Maternal Hypotension [ Time Frame: Baseline to 1 hour ]
   Number of patients who experienced maternal hypotension defined as a blood pressure (BP) >20% decline from baseline and need for vasopressor therapy

Eligibility Criteria

• 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)

Contacts and Locations

Locations

United States, Alabama

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States, 35249

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Mark F Powell, MD; University of Alabama at Birmingham

  Study Documents (Full-Text)

Documents provided by Mark Powell, University of Alabama at Birmingham:

Study Protocol and Statistical Analysis Plan  [PDF] April 29, 2020

More Information

• Responsible Party: Mark Powell, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03103100
• Other Study ID Numbers: F140903008
• First Posted: April 6, 2017
• Results First Posted: August 31, 2020
• Last Update Posted: August 31, 2020
• Last Verified: August 2020

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; Lidocaine; Bupivacaine; 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