Post-Op Lidocaine Patch

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Lidoderm 5 % Topical Patch; Other: Sham Topical Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03500211

OHSU IRB 16657

Details and patient eligibility

About

Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

Full description

The purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. Even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. A lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant patients who require a scheduled or non-urgent cesarean birth
• Patient able to receive neuraxial analgesia
• Patient able to give verbal and written consent for both cesarean birth and study

Exclusion criteria

• Patients requiring emergent cesarean birth
• Patients allergic to lidocaine or adhesive
• Patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth
• Patients using chronic oral neuromodulators
• Patients with cardiac disease or using anti-arrhythmic agents
• Patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus.
• Daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Lidoderm 5% Topical Patch

Experimental group

Description:

5% lidocaine patch applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second 5% lidocaine patch applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Treatment:

Drug: Lidoderm 5 % Topical Patch

Sham Topical Patch

Sham Comparator group

Description:

Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.

Treatment:

Other: Sham Topical Patch