Efficacy of Ultrasound Guided Erector Spinae Plane Block

Study Overview
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Brief Summary
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Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on intraoperative and postoperative hemodynamics and patient satisfaction

Detailed Description
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This prospective, double-blinded, randomized, controlled study was conducted at the period from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned written informed consent before the block performance. Patients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (BMI>40 kg/m2) were excluded from the study. Patients were randomly allocated into two equal groups by a computerized randomization table: ESPB group, and control group. The patient and the staff providing the postoperative care were blinded to the group assignment. ESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by Minia University Hospital. Anesthetic technique was standardized for all patients.

Official Title
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Efficacy of Ultrasound Guided Erector Spinae Plane Block in Patients Undergoning Abdominal Surgery

Conditions
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Hemodynamic Instability, Patient Satisfaction, Postoperative Pain, Regional Block

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age18-70 . Both gender. 4. ASA I-III . Exclusion Criteria: patient refuse Drug allergy. Morbid obesity (BMI >40 kg/m2). Psychiatric disorder. Opioid dependence .

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPB group<br>31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side). | Procedure: Erector spinae plane block<br>* The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes using ultrasound guide.<br>|
| Placebo Comparator: control group<br>31 patients anesthetized with the protocol followed by Minia University Hospital | Other: control<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Total Fentanyl Requirement | The total amount of postoperative fentanyl in milligram | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of First Post Operative Analgesic Request | the pain will be assisted based on the time for the first dose of rescue analgesia. | 24 hours | 
| heart rate (HR) | Hemodynamic | 24 hours | 
| mean arterial pressure (MAP ) | Hemodynamic | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESPB, postoperative pain, Regional block