Clinical trial NCT04706780: Hemi-diaphragmatic Paresis After Erector Spinae Plane Block
Official title: Hemi-diaphragmatic Paresis After Ultrasound-guided Erector Spinae Plane Block in Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Regional Anesthesia
Carotid Endarterectomy
Keywords: Regional anesthesia
Erector spinae plane block
Carotid endarterectomy
Ultrasound guidance
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: carotid endarterectomy

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

Detailed description: The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. The aim of the study is to assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Eligibility criteria: Inclusion Criteria:

* 18 - 85 years
* American Society of Anesthesiology (ASA) I-III
* elective carotid endarterectomy

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)
* emergency surgery

Primary outcomes:
measure: incidence of hemi-diaphragmatic paresis
timeFrame: 30 minutes
Secondary outcomes:
measure: opioid consumption
timeFrame: 1 hour
measure: postoperative analgesia consumption
timeFrame: 24 hours
measure: intraoperative local anesthetic consumption
timeFrame: 1 hour
measure: Postoperative Numeric Rating Scale (NRS) score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya TRH
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya TRH
name: Ali Sait Kavaklı
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.