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

Randomized Study of the Use of Synera for Pain Relief During Local Lidocaine Needle Skin Infiltration for Epidural Placement in Subjects Undergoing Elective Cesarean Section.

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Anxiety
• Intervention / Treatment: Drug: Synera

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore Unniversity Hospital

Participation Criteria

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:

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

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;

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Synera; Synera Pain Patch	Drug: Synera; Synera Pain Patch
No Intervention: No patch control; No intervention group
Sham Comparator: Control; Sham	Drug: Synera; Synera Pain Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rating of pain intensity upon lidocaine infiltration	30 minutes (following patch placement , upon lidocaine infiltration)

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject anxiety	1 hour (Upon admission to surgical holding area and after epidural placement)

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Alan Strobel, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Subject
• Other Study ID Numbers: 11-376