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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Synera

Synera Pain Patch

Group Type ACTIVE_COMPARATOR

Synera

Intervention Type DRUG

Synera Pain Patch

No patch control

No intervention group

Group Type NO_INTERVENTION

No interventions assigned to this group

Control

Sham

Group Type SHAM_COMPARATOR

Synera

Intervention Type DRUG

Synera Pain Patch

Interventions

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Synera

Synera Pain Patch

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes