Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 24-hour Postoperative Pain Scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Lidoderm 5 % Topical Patch (Drug)
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.
Intervention: Sham Topical Patch (Other)
Outcomes
Primary Outcomes
24-hour Postoperative Pain Scores
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 5-days Postoperative Narcotic Use(Postoperative (5 days))
Investigators
Catherine M Leclair, MD
Professor
Oregon Health and Science University