The Effect of Lidocaine Patch for Postoperative Pain

NCT ID: NCT04754451

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group P(placebo)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group L(lidocaine patch)

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

Group Type EXPERIMENTAL

Group L

Intervention Type DRUG

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

Interventions

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Group L

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

Intervention Type DRUG

Other Intervention Names

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lidotopcaplasma

Eligibility Criteria

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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.)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role collaborator

BON WOOK KOO

OTHER

Sponsor Role lead

Responsible Party

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BON WOOK KOO

associative professor of anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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BON WOOK KOO

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National Universuty, Bundang Hospital

Seongnam-si, Gyonggido, South Korea

Site Status

Countries

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South Korea

References

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Ahn HM, Oh HK, Kim DW, Kang SB, Koo BW, Lee PB. Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial. Trials. 2022 Sep 11;23(1):767. doi: 10.1186/s13063-022-06700-3.

Reference Type DERIVED
PMID: 36089597 (View on PubMed)

Other Identifiers

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LDPS

Identifier Type: -

Identifier Source: org_study_id