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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01775605
• Other study ID #: 11-376
• Status: Withdrawn
• Phase: Phase 4
• First received: December 10, 2012
• Last updated: May 13, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Drug:
• Synera
Synera Pain Patch

Locations

Country	Name	City	State
United States	North Shore Unniversity Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of pain intensity upon lidocaine infiltration		30 minutes (following patch placement , upon lidocaine infiltration)	No
Secondary	Subject anxiety		1 hour (Upon admission to surgical holding area and after epidural placement)	No