Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

Shoulder 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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Anesthesia, Regional
• Muscle Weakness
• Paresis
• Shoulder

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