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

Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: 1% Lidocaine; Drug: 0.25% Bupivacaine; Drug: Bupivacaine plus Lidocaine

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
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • UAB Department of Anesthesiology and Perioperative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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: Marcaine and Sensorcaine; Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Achieve an Adequate Epidural Level for Labor Analgesia	time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.	Baseline to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Achieve Adequate Analgesia	The number of patients who received an adequate epidural level of T10 or higher	Baseline to 1 hour
Degree of Motor Block	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.	Baseline to 1 hour
Number of Patients Who Experienced of Maternal Hypotension	Number of patients who experienced maternal hypotension defined as a blood pressure (BP) >20% decline from baseline and need for vasopressor therapy	Baseline to 1 hour

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2015
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Local anesthetic; Labor epidural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: F140903008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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