NCT03103100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

3.7 years

First QC Date

March 31, 2017

Results QC Date

July 17, 2020

Last Update Submit

August 17, 2020

Conditions

Labor Pain

Keywords

Local anestheticLabor epidural

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Number of Patients Who Achieve Adequate Analgesia

    Baseline to 1 hour

  • Degree of Motor Block

    Baseline to 1 hour

  • Number of Patients Who Experienced of Maternal Hypotension

    Baseline to 1 hour

Study Arms (3)

1% Lidocaine

ACTIVE COMPARATOR

Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine

Drug: 1% Lidocaine

0.25% Bupivacaine

ACTIVE COMPARATOR

Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine

Drug: 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.

Drug: Bupivacaine plus Lidocaine

Interventions

1% LidocaineDRUG

10 mL of 1% lidocaine

Also known as: Lidoderm, Xylocaine, Recticare, Anecream,, Solarcaine, Anestacon, Cutiecaine, Lidocoll,
1% Lidocaine
0.25% BupivacaineDRUG

10 mL of 0.25% bupivacaine

Also known as: Marcaine and Sensorcaine
0.25% Bupivacaine
Bupivacaine plus LidocaineDRUG

5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine

Also known as: Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,, Marcaine and Sensorcaine
Bupivacaine plus Lidocaine

Eligibility Criteria

Age19 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy females admitted for induction of labor
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

LidocaineLidodermBupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Mark Powell
Organization
University of Alabama at Birmingham
mfpowell@uabmc.edu
205-975-3328

Study Officials

  • Mark F Powell, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

October 8, 2015

Primary Completion

July 1, 2019

Study Completion

September 9, 2019

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)