ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation

Study Overview
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Brief Summary
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To evaluate the ability of Erector spina Plane Block decrease postoperative pain and analgesia requirements in patients undergoing percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.

Detailed Description
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Erector spina Plane Block is performed with guided ultrasound at T8 transverse process level lead to adequate intraprocedural and postoperative analgesia, in percutaneous Radiofrequency ablation of Hepatocellular Carcinomas.

Official Title
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Effect of Erector Spina Plain (ESP) Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation

Conditions
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Hepatic Carcinoma

Intervention / Treatment
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* Procedure: Group ESP
* Other: Non-blocked Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II patients Exclusion Criteria: history of allergy to the study medication refused to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector spinae plane block group (ESP)<br>Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group. Then standard sedation method is applied to all patients. | Procedure: Group ESP<br>* Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group<br>|
| Other: Control Group<br>This Group was received no intervention.Standard sedation method is applied to all patients. | Other: Non-blocked Group<br>* This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Scale assesment | A research assistant, blinded to the group allocation, interviewed patients and collected data at 6 times intervals (0.,2.,4.,6.,12 and 24 hours) in the 24 hours postprocedure. Patients will be asked to rate their pain using Numeric Pain Scale, where 0=no pain and 10=worst pain possible. | 24 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Age, BMI, ASA, Duration of procedure are recorded. | 24 hours after procedure | 
| Incidences of adverse effects (like nausea and vomiting) | Incidences of adverse effects (like nausea and vomitting) during the 24 hours postprocedure perİod is recorded at 6 times intervals (0,2,4,6,12,24 hours) | 24 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae block, Radiofrequency ablation, Hepatocellular Carcinomas, ultrasound