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

Study Overview
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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.

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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: ESPB group
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPB group<br>ESPB injection at T10 region with levobupivacaine 100mg (20 ml)+ Omnipaque10 ml | Drug: ESPB group<br>* ESPB injection at T10 region with Chirocaine 100mg(20 cc)+ Omnipaque 10cc<br>|
| Sham Comparator: Control group<br>ESPB injection at T10 region with 0.9% normal saline 20ml + Omnipaque10ml | Drug: Control group<br>* ESPB injection at T10 region with Normal saline 20cc + Omnipaque 10cc<br>* Other names: ESPB group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | approximately 12-24 hrs | 
| 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 | approximately 2-3 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | approximately 3 hours | 
| Postoperative recovery quality | We will assess the quality of recovery by using QoR-15 questionnaire at the postoperative day one | approximately 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, radiofrequency ablation, erector spinae plane block