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NCT05732181 Clinical Trial

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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05732181
Other study ID # B-ER-106-060
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2017
Est. completion date April 30, 2018

Study information
Verified date December 2022
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Placebo
patch without drugs

Locations
Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)
Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain severity visual analogue scale using a 10-point scale recorded two days to three days.
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