Efficacy of Ultrasound Guided Erector Spinae Plane Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371705
• Other study ID #: Efficacy of ESPB
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: May 2020
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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 .

Related Conditions & MeSH terms

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

Intervention

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.

Other:
• control
placebo

Locations

Country	Name	City	State
Egypt	Minia University	Minya	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Total Fentanyl Requirement	The total amount of postoperative fentanyl in milligram	24 hours
Secondary	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
Secondary	heart rate (HR)	Hemodynamic	24 hours
Secondary	mean arterial pressure (MAP )	Hemodynamic	24 hours