The Effect of Lidocaine Patch for Postoperative Pain

December 19, 2023 updated by: BON WOOK KOO

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyonggido
      • Seongnam-si, Gyonggido, Korea, Republic of
        • Seoul National Universuty, Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group P(placebo)
Attach two placebo patches for 12 hours, above and below the incision site.
Experimental: Group L(lidocaine patch)
Attach two lidocaine patches for 12 hours, above and below the incision site.
Drug: Group L
Attach two lidocaine patches for 12 hours, one above and below the incision site.
Other Names:
  • lidotopcaplasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after the anesthesia finished.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of cumulative analgesics
Time Frame: 24 hours after the anesthesia finished.
total amount of analgesics are measured for 24 hours after surgery.
24 hours after the anesthesia finished.
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
30 min after the anesthesia finished.
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
2 hours after the anesthesia finished.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BON WOOK KOO

Collaborators

SK Chemicals Co., Ltd.

Investigators

  • Principal Investigator: BON WOOK KOO, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Actual)

November 23, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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