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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05442814
Other study ID # EDinc
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date March 15, 2023

Study information

Verified date March 2024
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 anterior and posterior approach. Posterior 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 anterior approach provides effective analgesia in shoulder arthroscopy. The aim of our study was to compare anterior and posterior approaches of suprascapular nerve block in terms of analgesic efficacy and patient safety.


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 anterior approach and participant who underwent suprascapular nerve block with the posterior 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Procedure:
Posterior suprascapular block
Diaphragmatic thickness fraction will be evaluated in the participant underwent suprascapular block performed by posterior approach
Anterior suprascapular block
Diaphragmatic thickness fraction will be evaluated in the participant underwent suprascapular block performed by anterior approach

Locations

Country Name City State
Turkey Istanbul Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain at the first postoperatively 30th. Min. Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel. The first postoperative 30 minutes
Secondary Diaphragmatic movements Ratio of diaphragm thickness in end-inspiration and end-expiration measured by ultrasonography Baseline (Before the block performed) and 30 minutes after the end of surgery
Secondary Peroperatively opioid analgesic consumption (Remifentanil) milligram postoperative 0th.min
Secondary Postoperative opioid analgesic consumption (morphine) milligram postoperative 30th. Min
Secondary Postoperative opioid analgesic consumption (morphine) milligram postoperative 4 hours
Secondary Postoperative opioid analgesic consumption (morphine) milligram postoperative 6 hours
Secondary Postoperative opioid analgesic consumption (morphine) milligram postoperative 12 hours
Secondary Postoperative opioid analgesic consumption (morphine) milligram postoperative 24 hours
Secondary Postoperative pain at postoperative 4th. Hours Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel. at postoperative 4th. Hours
Secondary Postoperative pain at postoperative 6th. Hours Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel. at postoperative 6th. Hours
Secondary Postoperative pain at postoperative 12th. Hours Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel. at postoperative 12th. Hours
Secondary Postoperative pain at postoperative 24th. Hours Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel. at postoperative 24th. Hours
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