Predictive Model for Pain After TACE

NCT05545046 | Completed

• 1 other identifier: 2019-406
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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.

  0 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)

• 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.

  2 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)

• 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.

  4 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)

• 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.

  6 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)

• 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.

  12 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)

• 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.

  24 hour after TACE by the patients themselves using a Visual Analogue Scale (VAS)

Eligibility Criteria

• Age: 34 Years - 87 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead

Study Sites (1)

Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: September 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (1)