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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837742
• Other study ID #: 202101007RINA
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: January 18, 2023

Study information

• Verified date: April 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• ESPB group
ESPB injection at T10 region with Chirocaine 100mg(20 cc)+ Omnipaque 10cc
• Control group
ESPB injection at T10 region with Normal saline 20cc + Omnipaque 10cc

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Postoperative recovery quality	We will assess the quality of recovery by using QoR-15 questionnaire at the postoperative day one	approximately 2 days