Predictive Model for Pain After TACE

Hepatocellular Carcinoma Clinical Trial

Official title:

A Predictive Model for Pain After Transarterial Chemoembolization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545046
• Other study ID #: 2019-406
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2022
• Source: Yantai Yuhuangding Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Gender: All
• Age group: 34 Years to 87 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Yuhuangding Hospital	Yantai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)