Hemi-diaphragmatic Paresis and Erector Spinae Plane Block

Sponsor
Antalya Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05096377
Collaborator
(none)
20
1
3.8
5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: ESP block

Detailed Description

The aim of the study is to assess the effect of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Effect of Erector Spinae Plane Block on Hemidiaphragm Paresis in Shoulder Surgery
Actual Study Start Date :
Oct 7, 2021
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
ESP block group

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

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.

Outcome Measures

Primary Outcome Measures

  1. incidence of hemi-diaphragmatic paresis [30 minutes]

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

Secondary Outcome Measures

  1. intraoperative opioid consumption [2 hour]

    intraoperative opioid consumption will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation Muratpaşa Antalya Turkey 07100

Sponsors and Collaborators

  • Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Arzu Karaveli, Antalya TRH
  • Principal Investigator: Ali Sait Kavaklı, Antalya TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Antalya Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05096377
Other Study ID Numbers:
  • 8/12
First Posted:
Oct 27, 2021
Last Update Posted:
Feb 15, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antalya Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022