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

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Northwell Health

Status and phase

Withdrawn
Phase 4

Conditions

Anxiety
Pain

Treatments

Drug: Synera

Study type

Interventional

Funder types

Other

Identifiers

NCT01775605
11-376

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

0 participants in 3 patient groups

Synera
Active Comparator group
Description:
Synera Pain Patch
Treatment:
Drug: Synera
No patch control
No Intervention group
Description:
No intervention group
Control
Sham Comparator group
Description:
Sham
Treatment:
Drug: Synera

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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