Efficacy of Ultrasound Guided Erector Spinae Plane Block

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Patient Satisfaction; Regional Block; Postoperative Pain
• Interventions: Other: control; Procedure: Erector spinae plane block

• Registration Number: NCT04371705
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2018-10-15
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-30
• Status Verified: 2020-05
• Study First Posted: 2020-05-01
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Age18-70 .

2. Both gender.

3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control	31 patients anesthetized with the protocol followed by Minia University Hospital
ESPB group	Erector spinae plane block	31 patients Will undergo ultrasound guided ESP block with 40 ml bupivacaine 0.25% (20 ml on each side).

Primary Outcome Measures

Name	Time	Method
Postoperative Total Fentanyl Requirement	24 hours	The total amount of postoperative fentanyl in milligram

Secondary Outcome Measures

Name	Time	Method
Time of First Post Operative Analgesic Request	24 hours	the pain will be assisted based on the time for the first dose of rescue analgesia.
heart rate (HR)	24 hours	Hemodynamic
mean arterial pressure (MAP )	24 hours	Hemodynamic

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Minia, Egypt