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The Effect of Lidocaine Patch for Postoperative Pain

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04754451
Enrollment
32
Registered
2021-02-15
Start date
2021-03-15
Completion date
2022-11-30
Last updated
2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Brief 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

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.

Interventions

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

Sponsors

SK Chemicals Co., Ltd.
CollaboratorINDUSTRY
BON WOOK KOO
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
The pain score24 hours after the anesthesia finished.VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain

Secondary

MeasureTime frameDescription
The pain score30 min after the anesthesia finished.VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Total amount of cumulative analgesics24 hours after the anesthesia finished.total amount of analgesics are measured for 24 hours after surgery.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026