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

NCT04837742 | Completed

• 1 other identifier: 202101007RINA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; radiofrequency ablation; erector spinae plane block

Outcome Measures

Primary Outcomes (2)

• Visual analogue pain scale at postoperative day one

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

  approximately 12-24 hrs

• Drug spread level of erector spinae plane block

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

  approximately 2-3 hrs

Secondary Outcomes (2)

• Visual analogue pain scale at post-anesthesia care unit

  approximately 3 hours

• Postoperative recovery quality

  approximately 2 days

Study Arms (2)

ESPB group

EXPERIMENTAL

ESPB injection at T10 region with levobupivacaine 100mg (20 ml)+ Omnipaque10 ml

Drug: ESPB group

Control group

SHAM COMPARATOR

ESPB injection at T10 region with 0.9% normal saline 20ml + Omnipaque10ml

Drug: Control group

Interventions

ESPB group DRUG

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

ESPB group

Control group DRUG

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

Also known as: ESPB group

Control group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Control Groups

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ming-Shiang Wu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 14, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: May 26, 2023

Record last verified: 2021-04

Locations

TW (1)