Predictive Model for Pain After TACE

• Sponsor: Yantai Yuhuangding Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05545046
• Collaborator: (none)
• Enrollment: 228
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 228 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Predictive Model for Pain After Transarterial Chemoembolization
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Jan 31, 2021
• Actual Study Completion Date: Jan 31, 2021

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale (VAS) [0 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.

2. Visual Analogue Scale (VAS) [2 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.

3. Visual Analogue Scale (VAS) [4 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.

4. Visual Analogue Scale (VAS) [6 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.

5. Visual Analogue Scale (VAS) [12 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 34 Years to 87 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yuhuangding Hospital	Yantai	Shandong	China	264000

Sponsors and Collaborators

• Yantai Yuhuangding Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yantai Yuhuangding Hospital
• ClinicalTrials.gov Identifier: NCT05545046
• Other Study ID Numbers: 2019-406
• First Posted: Sep 19, 2022
• Last Update Posted: Sep 19, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Hepatocellular

Study Results

No Results Posted as of Sep 19, 2022