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

NCT ID: NCT03103100

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-08
• Study Completion Date: 2019-09-09

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.

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1% Lidocaine

Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine

Group Type: ACTIVE_COMPARATOR

1% Lidocaine

Intervention Type: DRUG

10 mL of 1% lidocaine

0.25% Bupivacaine

Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine

Group Type: ACTIVE_COMPARATOR

0.25% Bupivacaine

Intervention Type: DRUG

10 mL of 0.25% bupivacaine

Bupivacaine plus Lidocaine

Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.

Group Type: ACTIVE_COMPARATOR

Bupivacaine plus Lidocaine

Intervention Type: DRUG

5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine

Interventions

1% Lidocaine

10 mL of 1% lidocaine

Intervention Type: DRUG

0.25% Bupivacaine

10 mL of 0.25% bupivacaine

Intervention Type: DRUG

Bupivacaine plus Lidocaine

5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine

Intervention Type: DRUG

Other Intervention Names

Lidoderm, Xylocaine, Recticare, Anecream,; Solarcaine, Anestacon, Cutiecaine, Lidocoll,; Marcaine and Sensorcaine; Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,; Marcaine and Sensorcaine

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Mark Powell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark F Powell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

F140903008

Identifier Type: -

Identifier Source: org_study_id