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

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05732181

Collaborator

(none)

154

Enrollment

Location

Arms

11.7

Actual Duration (Months)

13.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer Post Ablation Syndrome	Drug: The skin lidocaine patch. Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 9, 2017

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine patch	Drug: 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. Drug: Placebo patch without drugs
No Intervention: Placebo

Arm

Intervention/Treatment

Experimental: Lidocaine patch

Drug: 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.

Drug: Placebo

patch without drugs

No Intervention: Placebo

Outcome Measures

Primary Outcome Measures

Pain severity [two days to three days.]
visual analogue scale using a 10-point scale recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.