Synera™ for Epidural Needle Insertion

November 27, 2007 updated by: IWK Health Centre

A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (ESTIMATE)

November 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2007

Last Update Submitted That Met QC Criteria

November 27, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • DWA-2007-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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