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Efficacy of Ultrasound Guided Erector Spinae Plane Block

Primary Purpose

Hemodynamic Instability, Patient Satisfaction, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae plane block
control
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hemodynamic Instability focused on measuring ESPB, postoperative pain, Regional block

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Minia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ESPB group

control group

Arm Description

31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side).

31 patients anesthetized with the protocol followed by Minia University Hospital

Outcomes

Primary Outcome Measures

Postoperative Total Fentanyl Requirement
The total amount of postoperative fentanyl in milligram

Secondary Outcome Measures

Time of First Post Operative Analgesic Request
the pain will be assisted based on the time for the first dose of rescue analgesia.
heart rate (HR)
Hemodynamic
mean arterial pressure (MAP )
Hemodynamic

Full Information

First Posted
April 27, 2020
Last Updated
May 5, 2020
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04371705
Brief Title
Efficacy of Ultrasound Guided Erector Spinae Plane Block
Official Title
Efficacy of Ultrasound Guided Erector Spinae Plane Block in Patients Undergoning Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Patient Satisfaction, Postoperative Pain, Regional Block
Keywords
ESPB, postoperative pain, Regional block

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Experimental
Arm Description
31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side).
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
31 patients anesthetized with the protocol followed by Minia University Hospital
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Postoperative Total Fentanyl Requirement
Description
The total amount of postoperative fentanyl in milligram
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time of First Post Operative Analgesic Request
Description
the pain will be assisted based on the time for the first dose of rescue analgesia.
Time Frame
24 hours
Title
heart rate (HR)
Description
Hemodynamic
Time Frame
24 hours
Title
mean arterial pressure (MAP )
Description
Hemodynamic
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagy S. Ali, MD
Organizational Affiliation
Minia University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Minia University
City
Minya
State/Province
Minia
ZIP/Postal Code
61511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Ultrasound Guided Erector Spinae Plane Block

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