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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04837742

Enrollment

Registered

2021-04-08

Start date

2021-04-14

Completion date

2023-01-18

Last updated

2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, radiofrequency ablation, erector spinae plane block

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.

Interventions

DRUGESPB group

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

DRUGControl group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026