Synera™ for Epidural Needle Insertion - Full Text View

Sponsors and Collaborators:	IWK Health Centre Duke University
Information provided by:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00564785

Purpose

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.

Condition	Intervention	Phase
Pain Associated With Epidural Needle Insertion	Drug: Synera(TM) Other: Placebo patch	Phase IV

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:

Subject VRS (0 - 11) with epidural needle insertion [ Time Frame: 1 hour ]

Secondary Outcome Measures:

Anesthesia provider perceived VRS [ Time Frame: 1 hour ]
Need for deep infiltration with local anesthesia [ Time Frame: 1 hour ]

Enrollment:	33
Study Start Date:	February 2007
Study Completion Date:	March 2007

Arms	Assigned Interventions
Placebo: Placebo Comparator	Other: Placebo patch placebo patch applied 20 minutes prior to epidural
Synera(TM): Experimental	Drug: Synera(TM) Synera(TM) patch applied 20 minutes prior to epidural

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564785

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

IWK Health Centre

Duke University

Investigators

Principal Investigator:

Ronald B George, MD FRCPC

IWK Health Centre

More Information

Study ID Numbers:	DWA-2007-001
Study First Received:	November 27, 2007
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00564785
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Lidocaine
Pain

ClinicalTrials.gov processed this record on January 15, 2009