Skip to main content
OpenTrials
Completed

NCT Number: NCT04754451

The Effect of Lidocaine Patch for Postoperative Pain

The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National Universuty, Bundang Hospital

Seongnam-si, Gyonggido, South Korea

About this study

After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists physical status I - II
  • Scheduled open unilateral herniorrhaphy

Exclusion criteria

  • body mass index (BMI) < 18.5 or ≥ 35 kg/m2
  • severe renal or hepatic dysfunction
  • allergy to amide-based local anesthetic agents
  • taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)

Treatment and study plan

Group L

Drug

Attach two lidocaine patches for 12 hours, one above and below the incision site.

Other names: lidotopcaplasma

Primary outcomes

  1. The pain score

    Time frame: 24 hours after the anesthesia finished.

    VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain

Secondary outcomes

  1. The pain score

    Time frame: 30 min after the anesthesia finished.

    VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain

  2. The pain score

    Time frame: 2 hours after the anesthesia finished.

    VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain

  3. Total amount of cumulative analgesics

    Time frame: 24 hours after the anesthesia finished.

    total amount of analgesics are measured for 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

BON WOOK KOO

Other

Collaborators

  • SK Chemicals Co., Ltd.

Registry information

Official study title

The Efficacy and Safety of 5% Lidocaine Patch for Postoperative Pain in Unilateral Inguinal Herniorrhaphy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Dec 26, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.