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Completed

NCT Number: NCT03500211

Post-Op Lidocaine Patch

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidoderm 5 % Topical Patch

Drug

Lidocaine patch after cesarean section delivery.

Other names: lidocaine patch

Sham Topical Patch

Other

Sham patch after cesarean section delivery.

Other names: sham patch

Primary outcomes

  1. 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".

  2. 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".

  3. 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".

  4. 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

  1. 5-days Postoperative Narcotic Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Lidocaine Patch for Adjunct Analgesia for Postoperative Cesarean Birth Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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