Liver Cancer, Post Ablation Syndrome
Conditions
Keywords
Hepatocellular carcinoma, Radiofrequency ablation, Lidocaine patch
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.
Interventions
DRUGThe 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.
DRUGPlacebo
patch without drugs
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | two days to three days. | visual analogue scale using a 10-point scale recorded |
Countries
Taiwan
Outcome results
None listed