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

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Information provided by (Responsible Party):
Northwell Health
ClinicalTrials.gov Identifier:
NCT01775605
First received: December 10, 2012
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Pain
Anxiety
Drug: Synera
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Rating of pain intensity upon lidocaine infiltration [ Time Frame: 30 minutes (following patch placement , upon lidocaine infiltration) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject anxiety [ Time Frame: 1 hour (Upon admission to surgical holding area and after epidural placement) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775605

Locations
United States, New York
North Shore Unniversity Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Alan Strobel, MD Northwell Health
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01775605     History of Changes
Other Study ID Numbers: 11-376 
Study First Received: December 10, 2012
Last Updated: May 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwell Health:
Subject

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016