Hemi-diaphragmatic Paresis After Erector Spinae Plane Block

NCT04706780 | Terminated

• 1 other identifier: 19/27
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regional Anesthesia; Carotid Endarterectomy

Keywords

Regional anesthesia; Erector spinae plane block; Carotid endarterectomy; Ultrasound guidance

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 (4)

• opioid consumption

  1 hour

• postoperative analgesia consumption

  24 hours

• intraoperative local anesthetic consumption

  1 hour

• Postoperative Numeric Rating Scale (NRS) score

  24 hours

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

carotid endarterectomy

You may qualify if:

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

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)
• emergency surgery

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (2)

• Ueshima H, Hiroshi O. RETRACTED: Erector spinae plane block for carotid endarterectomy. J Clin Anesth. 2018 Aug;48:11. doi: 10.1016/j.jclinane.2018.04.004. Epub 2018 Apr 21. No abstract available.

  PMID: 29684726 BACKGROUND

• 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

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: 4 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: January 20, 2021
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)