Synera™ for Epidural Needle Insertion

A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00564785

Enrollment

Registered

2007-11-28

Start date

2007-02-28

Completion date

2007-03-31

Last updated

2007-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Associated With Epidural Needle Insertion

Brief summary

We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.

Interventions

DRUGSynera(TM)

Synera(TM) patch applied 20 minutes prior to epidural

OTHERPlacebo patch

placebo patch applied 20 minutes prior to epidural

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural

Exclusion criteria

* hypersensitivity to any study medications

Design outcomes

Primary

Measure	Time frame
Subject VRS (0 - 11) with epidural needle insertion	1 hour

Secondary

Measure	Time frame
Anesthesia provider perceived VRS	1 hour
Need for deep infiltration with local anesthesia	1 hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026