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

May 24, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESPB group
ESPB injection at T10 region with levobupivacaine 100mg (20 ml)+ Omnipaque10 ml
Drug: ESPB group
ESPB injection at T10 region with Chirocaine 100mg(20 cc)+ Omnipaque 10cc
Sham Comparator: Control group
ESPB injection at T10 region with 0.9% normal saline 20ml + Omnipaque10ml
Drug: Control group
ESPB injection at T10 region with Normal saline 20cc + Omnipaque 10cc
Other Names:
  • ESPB group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
approximately 12-24 hrs
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
approximately 2-3 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
approximately 3 hours
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
approximately 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ming-Shiang Wu, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Actual)

January 18, 2023

Study Completion (Actual)

January 18, 2023

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202101007RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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