The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation

NCT ID: NCT05732181

Last Updated: 2023-02-16

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

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2018-04-30

Brief Summary

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Background: This study aims to test whether 5% lidocaine patches can reduce Radiofrequency ablation-induced pain. Methods: The study will enroll patients with hepatocellular carcinoma and schedule a radiofrequency ablation procedure. 200 patients will be invited to allocate randomly into study or control groups: pretreatment with a 5% lidocaine patch (LidotopⓇ) (Group A); pretreatment with a placebo patch (Group B); The skin patch is applied before Radiofrequency ablation (RFA) while admission, and is changed every day till discharge. Pain severity is evaluated by a visual analog scale using a 10-point scale recorded by a study nurse before RFA and after the procedure. The demographic data, hepatocellular carcinoma characteristics, analgesics usage, patient satisfaction with pain control, and visual analog scale will be compared between the two groups. Anticipated results: Pretreatment with 5% lidocaine patches is an effective and straight method of reducing Radiofrequency ablation-induced pain to reduce analgesics usage and improve patient satisfaction with pain control.

Detailed Description

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Conditions

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Liver Cancer Post Ablation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine patch

Group Type EXPERIMENTAL

The skin lidocaine patch.

Intervention Type DRUG

The skin patch is applied before RFA while admission and is changed every day till discharge. Pain severity is evaluated by visual analogue scale using a 10-point scale recorded before RFA and after the procedure.

Placebo

Intervention Type DRUG

patch without drugs

Placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The skin lidocaine patch.

The skin patch is applied before RFA while admission and is changed every day till discharge. Pain severity is evaluated by visual analogue scale using a 10-point scale recorded before RFA and after the procedure.

Intervention Type DRUG

Placebo

patch without drugs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adults diagnosed with liver cancer (HCC) by a physician and eligible for radiofrequency cautery (RFA).
2. Age is \> = 18 years.
3. Whether there is cirrhosis combined with cirrhosis, the child-pugh score of those with cirrhosis must score \< 8 points.
4. Communicative and able to express pain sensations.

Exclusion Criteria

1. Those who are allergic to Lidocaine.
2. Those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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B-ER-106-060

Identifier Type: -

Identifier Source: org_study_id

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