Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
|ClinicalTrials.gov Identifier: NCT03103100|
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : August 31, 2020
Last Update Posted : August 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Drug: 1% Lidocaine Drug: 0.25% Bupivacaine Drug: Bupivacaine plus Lidocaine||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study|
|Actual Study Start Date :||October 8, 2015|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||September 9, 2019|
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
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 Name: 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
- Time to Achieve an Adequate Epidural Level for Labor Analgesia [ 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.
- Number of Patients Who Achieve Adequate Analgesia [ Time Frame: Baseline to 1 hour ]The number of patients who received an adequate epidural level of T10 or higher
- Degree of Motor Block [ 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.
- Number of Patients Who Experienced of Maternal Hypotension [ 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103100
|United States, Alabama|
|UAB Department of Anesthesiology and Perioperative Medicine|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||Mark F Powell, MD||University of Alabama at Birmingham|