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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03103100
Other study ID # F140903008
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 8, 2015
Est. completion date September 9, 2019

Study information

Verified date August 2020
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date September 9, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
1% Lidocaine
10 mL of 1% lidocaine
0.25% Bupivacaine
10 mL of 0.25% bupivacaine
Bupivacaine plus Lidocaine
5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine

Locations

Country Name City State
United States UAB Department of Anesthesiology and Perioperative Medicine Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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