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Completed

NCT Number: NCT04371705

Efficacy of Ultrasound Guided Erector Spinae Plane Block

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

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Key information

Conditions

Hemodynamic Instability Behavior Health Behavior Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Satisfaction Postoperative Complications Postoperative Pain Regional Block Signs and Symptoms Treatment Adherence and Compliance

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University

Minya, Minya Governorate, 61511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age18-70 .
  • Both gender.
  • ASA I-III .

Exclusion criteria

  • patient refuse
  • Drug allergy.
  • Morbid obesity (BMI >40 kg/m2).
  • Psychiatric disorder.
  • Opioid dependence .

Treatment and study plan

Erector Spinae Plane Block

Procedure

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.

Control

Other

placebo

Primary outcomes

  1. Postoperative Total Fentanyl Requirement

    Time frame: 24 hours

    The total amount of postoperative fentanyl in milligram

Secondary outcomes

  1. Time of First Post Operative Analgesic Request

    Time frame: 24 hours

    the pain will be assisted based on the time for the first dose of rescue analgesia.

  2. heart rate (HR)

    Time frame: 24 hours

    Hemodynamic

  3. mean arterial pressure (MAP )

    Time frame: 24 hours

    Hemodynamic

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 1, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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