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

This study is not yet open for participant recruitment.
Verified January 2013 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01775605
First received: December 10, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

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 ]

Estimated Enrollment: 147
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775605

Contacts
Contact: Alan Strobel, MD 516-562-4887 astrobel@nshs.edu

Locations
United States, New York
North Shore Unniversity Hospital Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Alan Strobel, MD     516-562-4887     astrobel@nshs.edu    
Principal Investigator: Alan Strobel, MD            
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Alan Strobel, MD North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01775605     History of Changes
Other Study ID Numbers: 11-376
Study First Received: December 10, 2012
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Subject

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013