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Synera™ for Epidural Needle Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00564785
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : November 28, 2007
Duke University
Information provided by:
IWK Health Centre

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.

Condition or disease Intervention/treatment Phase
Pain Associated With Epidural Needle Insertion Drug: Synera(TM) Other: Placebo patch Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women
Study Start Date : February 2007
Study Completion Date : March 2007

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo patch
placebo patch applied 20 minutes prior to epidural
Experimental: Synera(TM) Drug: Synera(TM)
Synera(TM) patch applied 20 minutes prior to epidural

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

Secondary Outcome Measures :
  1. Anesthesia provider perceived VRS [ Time Frame: 1 hour ]
  2. Need for deep infiltration with local anesthesia [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00564785

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
IWK Health Centre
Duke University
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre Identifier: NCT00564785     History of Changes
Other Study ID Numbers: DWA-2007-001
First Posted: November 28, 2007    Key Record Dates
Last Update Posted: November 28, 2007
Last Verified: January 2007