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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014