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

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National Taiwan University

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Drug: ESPB group
Drug: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT04837742
202101007RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups

ESPB group
Experimental group
Description:
ESPB injection at T10 region with levobupivacaine 100mg (20 ml)+ Omnipaque10 ml
Treatment:
Drug: ESPB group
Control group
Sham Comparator group
Description:
ESPB injection at T10 region with 0.9% normal saline 20ml + Omnipaque10ml
Treatment:
Drug: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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