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NCT05096377 Clinical Trial

Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

Anesthesia, Regional Clinical Trial

Official title:
The Effect of Erector Spinae Plane Block on Hemidiaphragm Paresis in Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05096377
Other study ID # 8/12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 7, 2021
Est. completion date January 31, 2022

Study information
Verified date October 2021
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation Muratpasa Antalya

Sponsors (1)
Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation

Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of hemi-diaphragmatic paresis Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre. 30 minutes
Secondary intraoperative opioid consumption intraoperative opioid consumption will be recorded 2 hour
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