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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ESPB group
Control group
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, radiofrequency ablation, erector spinae plane block

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ESPB group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Visual analogue pain scale at post-anesthesia care unit
We will assess the pain intensity by using a 100-mm visual analogue scale at post-anesthesia care unit
Postoperative recovery quality
We will assess the quality of recovery by using QoR-15 questionnaire at the postoperative day one

Full Information

First Posted
April 6, 2021
Last Updated
May 24, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04837742
Brief Title
The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy
Official Title
The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, radiofrequency ablation, erector spinae plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Experimental
Arm Description
ESPB injection at T10 region with levobupivacaine 100mg (20 ml)+ Omnipaque10 ml
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
ESPB injection at T10 region with 0.9% normal saline 20ml + Omnipaque10ml
Intervention Type
Drug
Intervention Name(s)
ESPB group
Intervention Description
ESPB injection at T10 region with Chirocaine 100mg(20 cc)+ Omnipaque 10cc
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
ESPB group
Intervention Description
ESPB injection at T10 region with Normal saline 20cc + Omnipaque 10cc
Primary Outcome Measure Information:
Title
Visual analogue pain scale at postoperative day one
Description
We will assess the pain intensity by using a 100-mm visual analogue scale at postoperative day one
Time Frame
approximately 12-24 hrs
Title
Drug spread level of erector spinae plane block
Description
We will assess the numbers of vertebral levels of erector spinae block drug spreading by using computed tomography
Time Frame
approximately 2-3 hrs
Secondary Outcome Measure Information:
Title
Visual analogue pain scale at post-anesthesia care unit
Description
We will assess the pain intensity by using a 100-mm visual analogue scale at post-anesthesia care unit
Time Frame
approximately 3 hours
Title
Postoperative recovery quality
Description
We will assess the quality of recovery by using QoR-15 questionnaire at the postoperative day one
Time Frame
approximately 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shiang Wu
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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