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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2023-01-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ESPB group

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

Group Type EXPERIMENTAL

ESPB group

Intervention Type DRUG

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

Control group

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

Group Type SHAM_COMPARATOR

Control group

Intervention Type DRUG

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

Interventions

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ESPB group

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

Intervention Type DRUG

Control group

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

Intervention Type DRUG

Other Intervention Names

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ESPB group

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No