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

Primary Purpose

Liver Cancer, Post Ablation Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The skin lidocaine patch.
Placebo
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Hepatocellular carcinoma, Radiofrequency ablation, Lidocaine patch

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults diagnosed with liver cancer (HCC) by a physician and eligible for radiofrequency cautery (RFA). Age is > = 18 years. Whether there is cirrhosis combined with cirrhosis, the child-pugh score of those with cirrhosis must score < 8 points. Communicative and able to express pain sensations. Exclusion Criteria: Those who are allergic to Lidocaine. Those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lidocaine patch

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain severity
visual analogue scale using a 10-point scale recorded

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
February 7, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05732181
Brief Title
The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation
Official Title
The Role of 5% Lidocaine Patches in the Pain Control of Hepatocellular Carcinoma Patients Receiving Radiofrequency Ablation: A Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Post Ablation Syndrome
Keywords
Hepatocellular carcinoma, Radiofrequency ablation, Lidocaine patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine patch
Arm Type
Experimental
Arm Title
Placebo
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
The skin lidocaine patch.
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
patch without drugs
Primary Outcome Measure Information:
Title
Pain severity
Description
visual analogue scale using a 10-point scale recorded
Time Frame
two days to three days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults diagnosed with liver cancer (HCC) by a physician and eligible for radiofrequency cautery (RFA). Age is > = 18 years. Whether there is cirrhosis combined with cirrhosis, the child-pugh score of those with cirrhosis must score < 8 points. Communicative and able to express pain sensations. Exclusion Criteria: Those who are allergic to Lidocaine. Those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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