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

NCT05732181 | Completed

• 1 other identifier: B-ER-106-060
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Post Ablation Syndrome

Keywords

Hepatocellular carcinoma; Radiofrequency ablation; Lidocaine patch

Outcome Measures

Primary Outcomes (1)

• Pain severity

  visual analogue scale using a 10-point scale recorded

  two days to three days.

Study Arms (2)

Lidocaine patch

EXPERIMENTAL

Drug: The skin lidocaine patch.; Drug: Placebo

Placebo

NO INTERVENTION

Interventions

The skin lidocaine patch. 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.

Lidocaine patch

Placebo DRUG

patch without drugs

Lidocaine patch

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those who are allergic to Lidocaine.
• Those who suffer from skin diseases or have wounds on the abdomen that cannot be patched.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: February 16, 2023
• Study Start: May 9, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: February 16, 2023

Record last verified: 2022-12

Locations

TW (1)