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Completed

NCT Number: NCT05545046

Predictive Model for Pain After TACE

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.

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Key information

Conditions

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

Age range

34 year–87 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yuhuangding Hospital

Yantai, Shandong, 264000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yantai Yuhuangding Hospital

Other

Registry information

Official study title

A Predictive Model for Pain After Transarterial Chemoembolization

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2022
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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