Hemi-diaphragmatic Paresis After Erector Spinae Plane Block

Regional Anesthesia Clinical Trial

Official title:

Hemi-diaphragmatic Paresis After Ultrasound-guided Erector Spinae Plane Block in Carotid Endarterectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04706780
• Other study ID #: 19/27
• Status: Terminated
• Start date: January 20, 2021
• Est. completion date: July 7, 2021

Study information

• Verified date: January 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• 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 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

Related Conditions & MeSH terms

• Carotid Endarterectomy
• Paresis
• Regional Anesthesia

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	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

Ueshima H, Hiroshi O. 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. — 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	opioid consumption	intraoperative opioid consumption will be recorded	1 hour
Secondary	postoperative analgesia consumption	postoperative analgesia consumption for 24 hours will be recorded	24 hours
Secondary	intraoperative local anesthetic consumption	amount of intraoperative additional local anesthetic consumption will be recorded	1 hour
Secondary	Postoperative Numeric Rating Scale (NRS) score	postoperative pain assessment will be recorded using NRS score (NRS 0=no pain, NRS 10= most severe possible)	24 hours