UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35249, United States
NCT Number: NCT03103100
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.
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Notify Me19 year–60 year
Female
Interventional
Phase 3
Birmingham, Alabama, 35249, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 mL of 1% lidocaine
Other names: Lidoderm, Xylocaine, Recticare, Anecream,, Solarcaine, Anestacon, Cutiecaine, Lidocoll,
10 mL of 0.25% bupivacaine
Other names: Marcaine and Sensorcaine
5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Other names: Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,, Marcaine and Sensorcaine
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.
Time frame: Baseline to 1 hour
The number of patients who received an adequate epidural level of T10 or higher
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.
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
University of Alabama at Birmingham
Other
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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