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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04837742
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
9.6
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ESPB group
  • Drug: Control group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy
Actual Study Start Date :
Apr 14, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ESPB group

ESPB injection at T8 region with levobupivacaine 100mg (20 ml)+ Iohexol 10 ml

Drug: ESPB group
ESPB injection at T8 region with Chirocaine 100mg(20 cc)+ Omipaque 10cc
Sham Comparator: Control group

ESPB injection at T8 region with 0.9% normal saline 20ml + Iohexol 10ml

Drug: Control group
ESPB injection at T8 region with Normal saline 20cc + Omnipaque 10cc
Other Names:
  • ESPB group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual analogue pain scale at postoperative day one [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 [approximately 2-3 hrs]

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

    Secondary Outcome Measures

    1. Visual analogue pain scale at post-anesthesia care unit [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 [approximately 2 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04837742
    Other Study ID Numbers:
    • 202101007RINA
    First Posted:
    Apr 8, 2021
    Last Update Posted:
    Apr 15, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    hepatocellular carcinoma
    radiofrequency ablation
    erector spinae plane block
    Additional relevant MeSH terms:
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Apr 15, 2021