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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: ESPB group; Drug: Control group

• Registration Number: NCT04837742
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2021-04-14
• Primary Completion: 2023-01-18
• Study Completion: 2023-01-18
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB group	ESPB group	ESPB injection at T10 region with levobupivacaine 100mg (20 ml)+ Omnipaque10 ml
Control group	Control group	ESPB injection at T10 region with 0.9% normal saline 20ml + Omnipaque10ml

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
Postoperative recovery quality	approximately 2 days	We will assess the quality of recovery by using QoR-15 questionnaire at the postoperative day one
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan