Post-Op Lidocaine Patch

Phase 4

Completed

Conditions: Pain, Postoperative

Interventions: Drug: Lidoderm 5 % Topical Patch
Other: Sham Topical Patch

Registration Number: NCT03500211

Lead Sponsor: Oregon Health and Science University

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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidoderm 5% Topical Patch	Lidoderm 5 % Topical Patch	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.
Sham Topical Patch	Sham Topical Patch	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.

Primary Outcome Measures

Name	Time	Method
24-hour Postoperative Pain Scores	Postoperative (24 hours)	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".
36-hour Postoperative Pain Scores	Postoperative (36 hours)	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".
12-hour Postoperative Pain Scores	Postoperative (12 hours)	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".
48-hour Postoperative Pain Scores	Postoperative (48 hours)	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".

Secondary Outcome Measures

Name	Time	Method
5-days Postoperative Narcotic Use	Postoperative (5 days)	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.