Trial Outcomes & Findings for Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation (NCT NCT03103100)

Last Updated: 2020-08-31

Results Overview

time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

75 participants

Primary outcome timeframe

Baseline to 1 hour

Results posted on

2020-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	1% Lidocaine Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	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	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
Overall Study STARTED	25	25	25
Overall Study COMPLETED	23	25	23
Overall Study NOT COMPLETED	2	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	1% Lidocaine Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	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	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
Overall Study Adverse Event	1	0	0
Overall Study Physician Decision	1	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1% Lidocaine n=25 Participants Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	0.25% Bupivacaine n=25 Participants Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine	Bupivacaine Plus Lidocaine n=25 Participants 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 n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	75 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	75 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	75 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 1 hour

Population: 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.

time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=23 Participants Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	0.25% Bupivacaine n=25 Participants Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine	Bupivacaine Plus Lidocaine n=23 Participants 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
Time to Achieve an Adequate Epidural Level for Labor Analgesia	7.0 minutes Standard Deviation 3.9	11.0 minutes Standard Deviation 5.8	8.5 minutes Standard Deviation 4.6

SECONDARY outcome

Timeframe: Baseline to 1 hour

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

Outcome measures

Outcome measures
Measure	1% Lidocaine n=23 Participants Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	0.25% Bupivacaine n=25 Participants Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine	Bupivacaine Plus Lidocaine n=23 Participants 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
Number of Patients Who Achieve Adequate Analgesia	23 Participants	25 Participants	23 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=23 Participants Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	0.25% Bupivacaine n=25 Participants Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine	Bupivacaine Plus Lidocaine n=23 Participants 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
Degree of Motor Block	2.0 Bromage Score Standard Deviation 0.6	1.7 Bromage Score Standard Deviation 1.0	1.9 Bromage Score Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	1% Lidocaine n=23 Participants Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	0.25% Bupivacaine n=25 Participants Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine	Bupivacaine Plus Lidocaine n=23 Participants 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
Number of Patients Who Experienced of Maternal Hypotension	4 Participants	0 Participants	0 Participants

Adverse Events

1% Lidocaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

0.25% Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine Plus Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1% Lidocaine n=23 participants at risk Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine 1% Lidocaine: 10 mL of 1% lidocaine	0.25% Bupivacaine n=25 participants at risk Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine 0.25% Bupivacaine: 10 mL of 0.25% bupivacaine	Bupivacaine Plus Lidocaine n=23 participants at risk 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
Cardiac disorders Supraventricular tachycardia	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/25 • 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.	0.00% 0/23 • 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.

Additional Information

Dr. Mark Powell

University of Alabama at Birmingham

Phone: 205-975-3328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place