Efficacy of Ultrasound Guided Erector Spinae Plane Block

NCT ID: NCT04371705

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-12-01

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.

Conditions

Hemodynamic Instability; Patient Satisfaction; Postoperative Pain; Regional Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

ESPB group

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

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: 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 group

31 patients anesthetized with the protocol followed by Minia University Hospital

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

placebo

Interventions

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.

Intervention Type: PROCEDURE

control

placebo

Intervention Type: OTHER

Eligibility Criteria

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 .

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mokhtar Elshorbagy Hetta

assistant lecturarl

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagy S. Ali, MD

Role: STUDY_CHAIR

Minia University Hospital

Locations

Minia University

Minya, Minya Governorate, Egypt

Countries

Egypt

Other Identifiers

Efficacy of ESPB

Identifier Type: -

Identifier Source: org_study_id