Synera™ for Epidural Needle Insertion

Phase 4

Completed

• Conditions: Pain Associated With Epidural Needle Insertion
• Interventions: Other: Placebo patch; Drug: Synera(TM)

• Registration Number: NCT00564785
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-01
• Study Start: 2007-02
• Study Completion: 2007-03
• Study First Submitted: 2007-11-27
• Study First Submitted QC: 2007-11-27
• Last Update Submitted: 2007-11-27
• Study First Posted: 2007-11-28
• Last Update Posted: 2007-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo patch	-
Synera(TM)	Synera(TM)	-

Primary Outcome Measures

Name	Time	Method
Subject VRS (0 - 11) with epidural needle insertion	1 hour

Secondary Outcome Measures

Name	Time	Method
Anesthesia provider perceived VRS	1 hour
Need for deep infiltration with local anesthesia	1 hour

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States