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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03103100
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Actual Duration (Months): 47
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: 1% Lidocaine; Drug: 0.25% Bupivacaine; Drug: Bupivacaine plus Lidocaine	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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: Oct 8, 2015
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Sep 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; Other Names: Lidoderm, Xylocaine, Recticare, Anecream, Solarcaine, Anestacon, Cutiecaine, Lidocoll,
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 Names: 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; Other Names: Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten, Marcaine and Sensorcaine

Outcome Measures

Primary Outcome Measures

1. Time to Achieve an Adequate Epidural Level for Labor Analgesia [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.

Secondary Outcome Measures

1. Number of Patients Who Achieve Adequate Analgesia [Baseline to 1 hour]

   The number of patients who received an adequate epidural level of T10 or higher

2. Degree of Motor Block [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.

3. Number of Patients Who Experienced of Maternal Hypotension [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Department of Anesthesiology and Perioperative Medicine	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Mark F Powell, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 29, 2020

More Information

Publications

None provided.

• Responsible Party: Mark Powell, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03103100
• Other Study ID Numbers: F140903008
• First Posted: Apr 6, 2017
• Last Update Posted: Aug 31, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Mark Powell, Assistant Professor, University of Alabama at Birmingham: Local anesthetic; Labor epidural
• Additional relevant MeSH terms: Labor Pain; Lidocaine; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	1% Lidocaine	0.25% Bupivacaine	Bupivacaine Plus Lidocaine
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Period Title: Overall Study
STARTED	25	25	25
COMPLETED	23	25	23
NOT COMPLETED	2	0	2

Baseline Characteristics

Arm/Group Title	1% Lidocaine	0.25% Bupivacaine	Bupivacaine Plus Lidocaine	Total
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine	Total of all reporting groups
Overall Participants	25	25	25	75
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	25 100%	75 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	25 100%	25 100%	25 100%	75 100%
Male	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	25 100%	25 100%	25 100%	75 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	1% Lidocaine	0.25% Bupivacaine	Bupivacaine Plus Lidocaine
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Measure Participants	23	25	23
Mean (Standard Deviation) [minutes]	7.0 (3.9)	11.0 (5.8)	8.5 (4.6)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	1% Lidocaine	0.25% Bupivacaine	Bupivacaine Plus Lidocaine
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Measure Participants	23	25	23
Count of Participants [Participants]	23 92%	25 100%	23 92%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	1% Lidocaine	0.25% Bupivacaine	Bupivacaine Plus Lidocaine
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Measure Participants	23	25	23
Mean (Standard Deviation) [Bromage Score]	2.0 (0.6)	1.7 (1.0)	1.9 (0.9)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	1% Lidocaine	0.25% Bupivacaine	Bupivacaine Plus Lidocaine
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
Measure Participants	23	25	23
Count of Participants [Participants]	4 16%	0 0%	0 0%

Adverse Events

Time Frame	From start of epidural placement until 1 hour after placement.
Adverse Event Reporting Description	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.
Arm/Group Title	1% Lidocaine		0.25% Bupivacaine		Bupivacaine Plus Lidocaine
Arm/Group Description	Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine		Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 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. Bupivacaine plus Lidocaine: 5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
All Cause Mortality
	1% Lidocaine		0.25% Bupivacaine		Bupivacaine Plus Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/25 (0%)		0/23 (0%)
Serious Adverse Events
	1% Lidocaine		0.25% Bupivacaine		Bupivacaine Plus Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/25 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	1% Lidocaine		0.25% Bupivacaine		Bupivacaine Plus Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.3%)		0/25 (0%)		0/23 (0%)
Cardiac disorders
Supraventricular tachycardia	1/23 (4.3%)	1	0/25 (0%)	0	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.