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NCT04754451 Clinical Trial

The Effect of Lidocaine Patch for Postoperative Pain

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04754451
Other study ID # LDPS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 15, 2021
Est. completion date November 30, 2022

Study information
Verified date December 2023
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date November 30, 2022
Est. primary completion date November 23, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Group L
Attach two lidocaine patches for 12 hours, one above and below the incision site.

Locations
Country Name City State
Korea, Republic of Seoul National Universuty, Bundang Hospital Seongnam-si Gyonggido

Sponsors (2)
Lead Sponsor Collaborator
BON WOOK KOO SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The pain score 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 The pain score VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain 30 min after the anesthesia finished.
Secondary The pain score VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain 2 hours after the anesthesia finished.
Secondary Total amount of cumulative analgesics total amount of analgesics are measured for 24 hours after surgery. 24 hours after the anesthesia finished.
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