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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Lidocaine | Active Comparator | Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine |
|
| 0.25% Bupivacaine | Active Comparator | Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine |
|
| Bupivacaine plus Lidocaine | Active Comparator | Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Lidocaine | Drug | 10 mL of 1% lidocaine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Healthy females admitted for induction of labor
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| Name | Affiliation | Role |
|---|---|---|
| Mark F Powell, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Anesthesiology and Perioperative Medicine | Birmingham | Alabama | 35249 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Lidocaine | Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine |
| FG001 | 0.25% Bupivacaine | Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine |
| FG002 | Bupivacaine Plus Lidocaine | Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Lidocaine | Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine |
| BG001 | 0.25% Bupivacaine | Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | In the 1% lidocaine group, 1 participant experienced an adverse event and was removed from analysis and 1 participant was removed because they did not receive the study drug. In the bupivacaine plus lidocaine group 2 patients were removed because they did not receive the study drug. | Posted | Mean | Standard Deviation | minutes | Baseline to 1 hour |
|
From start of epidural placement until 1 hour after placement.
In the 1% lidocaine group, 1 participant experienced an adverse event and was removed from analysis and 1 participant was removed because they did not receive the study drug. In the bupivacaine plus lidocaine group 2 patients were removed because they did not receive the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1% Lidocaine | Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Powell | University of Alabama at Birmingham | 205-975-3328 | mfpowell@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2020 | Jul 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C511998 | Lidoderm |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 0.25% Bupivacaine | Drug | 10 mL of 0.25% bupivacaine |
|
|
| Bupivacaine plus Lidocaine | Drug | 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine |
|
|
| Baseline to 1 hour |
| 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 |
| BG002 | Bupivacaine Plus Lidocaine | Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine |
| OG002 | Bupivacaine Plus Lidocaine | Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine |
|
|
| Secondary | Number of Patients Who Achieve Adequate Analgesia | The number of patients who received an adequate epidural level of T10 or higher | In the 1% lidocaine group, 1 participant experienced an adverse event and was removed from analysis and 1 participant was removed because they did not receive the study drug. In the bupivacaine plus lidocaine group 2 patients were removed because they did not receive the study drug. | Posted | Count of Participants | Participants | 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. | In the 1% lidocaine group, 1 participant experienced an adverse event and was removed from analysis and 1 participant was removed because they did not receive the study drug. In the bupivacaine plus lidocaine group 2 patients were removed because they did not receive the study drug. | Posted | Mean | Standard Deviation | Bromage Score | 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 | In the 1% lidocaine group, 1 participant experienced an adverse event and was removed from analysis and 1 participant was removed because they did not receive the study drug. In the bupivacaine plus lidocaine group 2 patients were removed because they did not receive the study drug. | Posted | Count of Participants | Participants | Baseline to 1 hour |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
| EG001 | 0.25% Bupivacaine | Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Bupivacaine Plus Lidocaine | Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine | 0 | 23 | 0 | 23 | 0 | 23 |
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| Aniline Compounds |
| D000588 | Amines |