Completed

NCT Number: NCT00564785

Synera™ for Epidural Needle Insertion

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.

Completed

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Key information

Conditions

Pain Associated With Epidural Needle Insertion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synera(TM)

Drug

Synera(TM) patch applied 20 minutes prior to epidural

Placebo patch

Other

placebo patch applied 20 minutes prior to epidural

Primary outcomes

Subject VRS (0 - 11) with epidural needle insertion

Time frame: 1 hour

Secondary outcomes

Anesthesia provider perceived VRS

Time frame: 1 hour
Need for deep infiltration with local anesthesia

Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

Duke University

Registry information

Official study title

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

Important dates

Study start: 2007
Study completion: 2007
First posted: Nov 28, 2007
Registry last updated: Nov 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.