Phase 3 N=75 Randomized Triple-blind Prevention

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

Labor Pain

Bottom Line

View on ClinicalTrials.gov: NCT03103100 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Time to Achieve an Adequate Epidural Level for Labor Analgesia — 7.0; 11.0; 8.5 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 1% Lidocaine (Drug); 0.25% Bupivacaine (Drug); Bupivacaine plus Lidocaine (Drug)
Age: Adult · 19+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Achieve an Adequate Epidural Level for Labor Analgesia	7.0; 11.0; 8.5	—
SECONDARY Number of Patients Who Achieve Adequate Analgesia	23; 25; 23	—
SECONDARY Degree of Motor Block	2.0; 1.7; 1.9	—
SECONDARY Number of Patients Who Experienced of Maternal Hypotension	4; 0; 0	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03103100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.