Study of Use of Synera for Pain During Local Skin Infiltration With Lidocaine Before Epidural Placement

Phase 4

Withdrawn

• Conditions: Pain; Anxiety
• Interventions: Drug: Synera

• Registration Number: NCT01775605
• Lead Sponsor: Northwell Health

Brief Summary

Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.

The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Over 18 years old;
• Undergoing pre-scheduled cesarean section;
• Expected singleton birth;
• BMI <=35kg.m-2;

Read More

Exclusion Criteria

• Undergoing emergency cesarean section;
• Complications during pregnancy;
• History of hypersensitivity to study medication(lidocaine or tetracaine) or para-aminobenzoic acid;
• Allergies to bird proteins, feathers, or egg products; or any other skin allergies; dermatitis an open wound at the patch site or a history of difficult epidural placement;

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Synera	Sham
Synera	Synera	Synera Pain Patch

Primary Outcome Measures

Name	Time	Method
Rating of pain intensity upon lidocaine infiltration	30 minutes (following patch placement , upon lidocaine infiltration)

Secondary Outcome Measures

Name	Time	Method
Subject anxiety	1 hour (Upon admission to surgical holding area and after epidural placement)

Trial Locations

Locations (1)

North Shore Unniversity Hospital; 🇺🇸 Manhasset, New York, United States