Predictive Model for Pain After TACE

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05545046
• Lead Sponsor: Yantai Yuhuangding Hospital

Brief Summary

The main aim of this study was to analyze the risk factors that helped to predict the pain after transarterial chemoembolization (TACE).This was a prospective observational study enrolled all hepatocellular carcinoma (HCC) patients undergoing TACE in our hospital. Pain score at rest was assessed after TACE by the patients themselves using a Visual Analogue Scale (VAS). Independent variables such as age, gender, tumor location, tumor size and number, drug delivery method and presence of portal vein tumor thrombosis (PVTT) were recorded and analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• A diagnosis of HCC was confirmed either histologically or based on consistent findings obtained from at least two imaging techniques.

Exclusion Criteria

• patients aged < 18 year
• significant heart or lung dysfunction
• use of additional analgesics to relieve pain during TACE
• cognitive impairment
• use of psychiatric medications
• drug or alcohol abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	24 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)	After local anesthesia with an injection of 10 mL of 2% lidocaine, all the patients enrolled in this study received percutaneous femoral artery puncture. An arterial catheter was inserted into the femoral artery and subsequently placed in the hepatic artery. Then, a conventional TACE or a DEB-TACE procedure was performed. After TACE, all patients received supportive treatment including antiemetics, liver protection, non-steroidal anti-inflammatory drugs.

Trial Locations

Locations (1)

Yuhuangding Hospital; 🇨🇳 Yantai, Shandong, China