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

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
1% Lidocaine
0.25% Bupivacaine
Bupivacaine plus Lidocaine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Pain focused on measuring Local anesthetic, Labor epidural

Eligibility Criteria

19 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • UAB Department of Anesthesiology and Perioperative Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1% Lidocaine

0.25% Bupivacaine

Bupivacaine plus Lidocaine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients Who Achieve Adequate Analgesia
The number of patients who received an adequate epidural level of T10 or higher
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.
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

Full Information

First Posted
March 31, 2017
Last Updated
August 17, 2020
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03103100
Brief Title
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
Official Title
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2015 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Local anesthetic, Labor epidural

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% Lidocaine
Arm Type
Active Comparator
Arm Description
Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine
Arm Title
0.25% Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine
Arm Title
Bupivacaine plus Lidocaine
Arm Type
Active Comparator
Arm Description
Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine.
Intervention Type
Drug
Intervention Name(s)
1% Lidocaine
Other Intervention Name(s)
Lidoderm, Xylocaine, Recticare, Anecream,, Solarcaine, Anestacon, Cutiecaine, Lidocoll,
Intervention Description
10 mL of 1% lidocaine
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine
Other Intervention Name(s)
Marcaine and Sensorcaine
Intervention Description
10 mL of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine plus Lidocaine
Other Intervention Name(s)
Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,, Marcaine and Sensorcaine
Intervention Description
5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Primary Outcome Measure Information:
Title
Time to Achieve an Adequate Epidural Level for Labor Analgesia
Description
time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.
Time Frame
Baseline to 1 hour
Secondary Outcome Measure Information:
Title
Number of Patients Who Achieve Adequate Analgesia
Description
The number of patients who received an adequate epidural level of T10 or higher
Time Frame
Baseline to 1 hour
Title
Degree of Motor Block
Description
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.
Time Frame
Baseline to 1 hour
Title
Number of Patients Who Experienced of Maternal Hypotension
Description
Number of patients who experienced maternal hypotension defined as a blood pressure (BP) >20% decline from baseline and need for vasopressor therapy
Time Frame
Baseline to 1 hour

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Healthy females admitted for induction of labor
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark F Powell, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Department of Anesthesiology and Perioperative Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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