Subomohyoid and Supraspinous Approaches of Suprascapular Block

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05442814
Collaborator
(none)
60
1
2
12
5

Study Details

Study Description

Brief Summary

Suprascapular nerve is a mixed motor and sensory peripheral nerve arising from the superior trunk of brachial plexus.The suprascapular nerve runs through the posterior triangle of the neck, anterior of the trapezius muscle and dorsal of the omohyoid muscle, in direction of the scapula. Suprascapular nerve block is performed by subomohyoid and supraspinous approach. Supraspinous approach of the suprascapular nerve block has been shown for many years to provide effective analgesia in the shoulder region for the chronic and acute pain. There are studies showing that suprascapular block with subomohyoid approach provides effective analgesia in shoulder arthroscopy.

The aim of our study was to compare subomohyoid and supraspinous approaches of suprascapular nerve block in terms of analgesic efficacy and patient safety.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Supraspinous suprascapular block
  • Procedure: Subomohyoid suprascapular block
N/A

Detailed Description

This study is a prospective randomized clinical trial will be conducted between March 2022 and March 2023.Participant will divide into two groups as participant who underwent suprascapular nerve block with the subomohyoid approach and participant who underwent suprascapular nerve block with the supraspinous approach. Bupivacaine 5 ml %0.5 will be injected both group. Diaphragmatic thickness fraction will be evaluated with ultrasound left and right 7.-8. subcostal anterior axillary border with the participant with the semi-sitting position. Diaphragmatic thickness fraction will measure before the block and after 30 minutes the surgery. Participants will administered intravenous morphine patient controlled analgesia for 24 hours stay. The amount of opioid analgesics given in both groups will be determined (in mg). Postoperative 4th, 6th, 12th, 24th hour Visual Analogue Scale scores of the participants and opioid consumptions until that hours will be evaluated. An addition participant will be determined according to the surgery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
participant with subomohyoid suprascapular block ,group 1 participant with supraspinous suprascapular block, group 2participant with subomohyoid suprascapular block ,group 1 participant with supraspinous suprascapular block, group 2
Masking:
Single (Outcomes Assessor)
Masking Description:
sealed envelope
Primary Purpose:
Treatment
Official Title:
Comparison of Subomohyoid and Supraspinous Approaches of Suprascapular Block in Shoulder Surgeries
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Supraspinous suprascapular block

Suprascapular block performed by supraspinous approach

Procedure: Supraspinous suprascapular block
Diaphragmatic thickness fraction will be evaluated in the participant underwent suprascapular block performed by supraspinous approach

Active Comparator: Subomohyoid suprascapular block

Suprascapular block performed by subomohyoid approach

Procedure: Subomohyoid suprascapular block
Diaphragmatic thickness fraction will be evaluated in the participant underwent suprascapular block performed by subomohyoid approach

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain [The first postoperative 30 minutes]

    Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel.

  2. Pain rating [Postoperative 4 hours]

    Measured by VAS ( Visual analog scale).

  3. Pain Rating [Postoperative 6 hours]

    Measured by VAS ( Visual analog scale).

  4. Pain Rating [Postoperative 12 hours]

    Measured by VAS ( Visual analog scale).

  5. Pain Rating [Postoperative 24 hours]

    Measured by VAS ( Visual analog scale).

Secondary Outcome Measures

  1. Diaphragmatic movements [Baseline (Before the block performed) and 30 minutes after the end of surgery]

    Ratio of diaphragm thickness in end-inspiration and end-expiration measured by ultrasonography

  2. Postoperative opioid analgesic consumption (morphine) [postoperative 4 hours]

    milligram

  3. Postoperative opioid analgesic consumption (morphine) [postoperative 6 hours]

    milligram

  4. Postoperative opioid analgesic consumption (morphine) [postoperative 12 hours]

    milligram

  5. Postoperative opioid analgesic consumption (morphine) [postoperative 24 hours]

    milligram

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient who accepts to study protocol

  • Scheduled for shoulder surgery

  • Between the ages of 18 and 80

Exclusion Criteria:
  • Patients with coagulopathy

  • Patients with a history of local anesthetic drug allergy and toxicity

  • Patients with advanced organ failure

  • Patients with mental retardation

  • Patients with infection present at the injection site

  • Patients with diaphragm paralysis

  • Pregnant patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medeniyet University Istanbul Turkey 34722

Sponsors and Collaborators

  • Istanbul Medeniyet University

Investigators

  • Principal Investigator: Ebru Girgin Dinç, MD, İstanbul Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ebru Girgin Dinç, Principal Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT05442814
Other Study ID Numbers:
  • EDinc
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
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
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ebru Girgin Dinç, Principal Investigator, Istanbul Medeniyet University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022