NCT00564785

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_4

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

February 1, 2007

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
Last Updated

November 28, 2007

Status Verified

January 1, 2007

First QC Date

November 27, 2007

Last Update Submit

November 27, 2007

Conditions

Pain Associated With Epidural Needle Insertion

Outcome Measures

Primary Outcomes (1)

  • Subject VRS (0 - 11) with epidural needle insertion

    1 hour

Secondary Outcomes (2)

  • Anesthesia provider perceived VRS

    1 hour

  • Need for deep infiltration with local anesthesia

    1 hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo patch

Synera(TM)

EXPERIMENTAL
Drug: Synera(TM)

Interventions

Synera(TM)DRUG

Synera(TM) patch applied 20 minutes prior to epidural

Synera(TM)
Placebo patchOTHER

placebo patch applied 20 minutes prior to epidural

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • hypersensitivity to any study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Ronald B George, MD FRCPC

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

February 1, 2007

Study Completion

March 1, 2007

Last Updated

November 28, 2007

Record last verified: 2007-01

Locations

US(1)