Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

NCT05096377 | Completed

• 1 other identifier: 8/12
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Regional; Shoulder

Keywords

Regional Anesthesia; Shoulder Surgery; Hemidiaphragmatic Paresis; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• intraoperative opioid consumption

  2 hour

Study Arms (1)

ESP block group

Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.

Other: ESP block

Interventions

ESP block OTHER

ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.

ESP block group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

shoulder surgery

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Muratpaşa, Antalya, 07100, Turkey (Türkiye)

Location

Related 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 31397702 BACKGROUND

Study Officials

• Arzu Karaveli

  Antalya TRH

  PRINCIPAL INVESTIGATOR

• Ali Sait Kavaklı

  Antalya TRH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: October 7, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 15, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)