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Completed

NCT Number: NCT05732181

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Drug

patch without drugs

Primary outcomes

  1. Pain severity

    Time frame: two days to three days.

    visual analogue scale using a 10-point scale recorded

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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