NCT04371705

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

April 27, 2020

Last Update Submit

May 5, 2020

Conditions

Hemodynamic InstabilityPatient SatisfactionPostoperative PainRegional Block

Keywords

ESPBpostoperative painRegional block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Total Fentanyl Requirement

    The total amount of postoperative fentanyl in milligram

    24 hours

Secondary Outcomes (3)

  • Time of First Post Operative Analgesic Request

    24 hours

  • heart rate (HR)

    24 hours

  • mean arterial pressure (MAP )

    24 hours

Study Arms (2)

ESPB group

EXPERIMENTAL

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

Procedure: Erector spinae plane block

control group

PLACEBO COMPARATOR

31 patients anesthetized with the protocol followed by Minia University Hospital

Other: control

Interventions

Erector spinae plane blockPROCEDURE

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.

ESPB group
controlOTHER

placebo

control group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

Location

MeSH Terms

Conditions

Patient SatisfactionPain, Postoperative

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nagy S. Ali, MD

    Minia University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturarl

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 1, 2020

Study Start

October 15, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)