Post-Op Lidocaine Patch

Oregon Health and Science University50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain, Postoperative

Interventions

Lidoderm 5 % Topical PatchDRUG

Lidocaine patch after cesarean section delivery.

Sham Topical PatchOTHER

Sham patch after cesarean section delivery.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

12-hour Postoperative Pain Scores

To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

Time frame: Postoperative (12 hours)

24-hour Postoperative Pain Scores

To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

Time frame: Postoperative (24 hours)

36-hour Postoperative Pain Scores

To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

Time frame: Postoperative (36 hours)

48-hour Postoperative Pain Scores

To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0="no pain" and 100="the worst pain you have ever felt".

Time frame: Postoperative (48 hours)

Secondary Outcomes

5-days Postoperative Narcotic Use

To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.

Data from ClinicalTrials.gov

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