Post-Op Lidocaine Patch

Pain, Postoperative Clinical Trial

Official title:

Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500211
• Other study ID #: OHSU IRB 16657
• Status: Completed
• Phase: Phase 4
• Start date: March 13, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Lidoderm 5 % Topical Patch
Lidocaine patch after cesarean section delivery.

Other:
• Sham Topical Patch
Sham patch after cesarean section delivery.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Postoperative (12 hours)
Primary	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".	Postoperative (24 hours)
Primary	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".	Postoperative (36 hours)
Primary	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".	Postoperative (48 hours)
Secondary	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.	Postoperative (5 days)