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Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05096377
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

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

Condition or disease Intervention/treatment
Anesthesia, Regional Shoulder Other: ESP block

Detailed Description:
The aim of the study is to assess the effect of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: The Effect of Erector Spinae Plane Block on Hemidiaphragm Paresis in Shoulder Surgery
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : December 7, 2021
Estimated Study Completion Date : December 21, 2021

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. intraoperative opioid consumption [ Time Frame: 2 hour ]
    intraoperative opioid consumption will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
shoulder surgery
Criteria

Inclusion Criteria:

  • 18 - 85 years
  • American Society of Anesthesiology (ASA) I-III
  • elective shoulder surgery

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096377


Contacts
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Contact: Arzu Karaveli +902422494400 arzukaraveli@hotmail.com

Locations
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Turkey
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation Recruiting
Muratpaşa, Antalya, Turkey, 07100
Contact: Antalya Training and Research Hospital    +902422494400      
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Principal Investigator: Arzu Karaveli Antalya TRH
Principal Investigator: Ali Sait Kavaklı Antalya TRH
Publications:
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05096377    
Other Study ID Numbers: 8/12
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antalya Training and Research Hospital:
Regional Anesthesia
Shoulder Surgery
Hemidiaphragmatic Paresis
Erector Spinae Plane Block
Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Neurologic Manifestations
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes