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Synera™ for Epidural Needle Insertion

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00564785
First received: November 27, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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 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

  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

No publications provided

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

ClinicalTrials.gov processed this record on May 19, 2013