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NCT Number: NCT04837742

The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy

This is a double blind, randomized controlled trial to evaluate the efficacy of ESPB(Erector Spinae Plane Block) on postoperative analgesia in RFA( Radiofrequency Ablation therapy). We will include 80 patients, and randomly assign to ESPB(Chirocaine) group and control group(normal saline).We deduce Erector spinae plane block can be use as a postoperative analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma.

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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

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

Computed tomography guided radiofrequency ablation of hepatocellular carcinoma(HCC) has became a popular way to treat HCC. Although the wound is small and the patients can discharge on the next day, they have to suffer from moderate to severe pain. Nowadays Erector spinae plane block has been applied to many surgery as a postoperative analgesic strategy. We deduce Erector spinae plane block can be use as a postoperative analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma. Besides, we will add contrast medium to evaluate the spread area of local anesthetics.

Who can participate

Healthy volunteers accepted: No

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

Patients undergoing computed tomography guided radiofrequency ablation of hepatic tumor under scheduled general anesthesia, and fulfilled one of following inclusion criteria:

  • diameter of hepatic tumor is larger than 2 cm
  • distance of tumor site is near the hepatic surface < 2cm

Exclusion criteria

  • A history of allergic reaction to local anesthetics or iohexol
  • Renal insufficiency, creatinine clearance < 30mL/min
  • Coagulopathy or other bleeding disorder that cannot perform nerve block
  • Under pregnancy or lactation
  • Opioid tolerant patient

Treatment and study plan

ESPB group

Drug

ESPB injection at T10 region with Chirocaine 100mg(20 cc)+ Omnipaque 10cc

Control group

Drug

ESPB injection at T10 region with Normal saline 20cc + Omnipaque 10cc

Other names: ESPB group

Primary outcomes

  1. Visual analogue pain scale at postoperative day one

    Time frame: approximately 12-24 hrs

    We will assess the pain intensity by using a 100-mm visual analogue scale at postoperative day one

  2. Drug spread level of erector spinae plane block

    Time frame: approximately 2-3 hrs

    We will assess the numbers of vertebral levels of erector spinae block drug spreading by using computed tomography

Secondary outcomes

  1. Visual analogue pain scale at post-anesthesia care unit

    Time frame: approximately 3 hours

    We will assess the pain intensity by using a 100-mm visual analogue scale at post-anesthesia care unit

  2. Postoperative recovery quality

    Time frame: approximately 2 days

    We will assess the quality of recovery by using QoR-15 questionnaire at the postoperative day one

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2021
Registry last updated
May 26, 2023

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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