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

Not Applicable

Completed

• Conditions: Post Ablation Syndrome; Liver Cancer
• Interventions: Drug: The skin lidocaine patch.; Drug: Placebo

• Registration Number: NCT05732181
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-09
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2022-12
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine patch	The skin lidocaine patch.	-
Lidocaine patch	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain severity	two days to three days.	visual analogue scale using a 10-point scale recorded

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan