Efficacy of Ultrasound Guided Erector Spinae Plane Block

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Patient Satisfaction; Hemodynamic Instability; Regional Block
• Intervention / Treatment: Procedure: Erector spinae plane block; Other: control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minia
    • Minya, Minia, Egypt, 61511
      • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age18-70 .
2. Both gender.

4. ASA I-III .

Exclusion Criteria:

1. patient refuse
2. Drug allergy.
3. Morbid obesity (BMI >40 kg/m2).
4. Psychiatric disorder.
5. Opioid dependence .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESPB group; 31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side).	Procedure: Erector spinae plane block; 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.
Placebo Comparator: control group; 31 patients anesthetized with the protocol followed by Minia University Hospital	Other: control; placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Chair: Nagy S. Ali, MD, Minia University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain; Regional block; ESPB
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Efficacy of ESPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No