Hemi-diaphragmatic Paresis After Erector Spinae Plane Block

July 28, 2021 updated by: Antalya Training and Research Hospital

Hemi-diaphragmatic Paresis After Ultrasound-guided Erector Spinae Plane Block in Carotid Endarterectomy

To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. The aim of the study is to assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07100
        • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

carotid endarterectomy

Description

Inclusion Criteria:

  • 18 - 85 years
  • American Society of Anesthesiology (ASA) I-III
  • elective carotid endarterectomy

Exclusion Criteria:

  • patient's refusal
  • under 18 years of age or over 65 years of age
  • ASA IV and above
  • known allergy to local anaesthetic drugs
  • the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
  • history of neurological and/or neuromucular disease
  • history of severe bronchopulmonary disease
  • a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)
  • emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ESP block group
Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
Other: ESP block
ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of hemi-diaphragmatic paresis
Time Frame: 30 minutes
Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: 1 hour
intraoperative opioid consumption will be recorded
1 hour
postoperative analgesia consumption
Time Frame: 24 hours
postoperative analgesia consumption for 24 hours will be recorded
24 hours
intraoperative local anesthetic consumption
Time Frame: 1 hour
amount of intraoperative additional local anesthetic consumption will be recorded
1 hour
Postoperative Numeric Rating Scale (NRS) score
Time Frame: 24 hours
postoperative pain assessment will be recorded using NRS score (NRS 0=no pain, NRS 10= most severe possible)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2021

Primary Completion (ACTUAL)

July 7, 2021

Study Completion (ACTUAL)

July 7, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (ACTUAL)

January 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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