Anterior and Posterior Approaches of Suprascapular Nerve Block
Primary Purpose
Shoulder Pain, Postoperative Pain, Diaphragmatic Paralysis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Posterior suprascapular block
Anterior suprascapular block
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Nerve Block, Diaphragmatic paralysis, Postoperative pain, Suprascapular block, Subomohyoid suprascapular block, Posterior Suprascapular block, Anterior Suprascapular block
Eligibility Criteria
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
Sites / Locations
- Istanbul Medeniyet University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Posterior suprascapular block
Anterior suprascapular block
Arm Description
Suprascapular block performed by posterior approach
Suprascapular block performed by anterior approach
Outcomes
Primary Outcome Measures
Postoperative pain
Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel.
Pain rating
Measured by VAS ( Visual analog scale).
Pain Rating
Measured by VAS ( Visual analog scale).
Pain Rating
Measured by VAS ( Visual analog scale).
Pain Rating
Measured by VAS ( Visual analog scale).
Secondary Outcome Measures
Diaphragmatic movements
Ratio of diaphragm thickness in end-inspiration and end-expiration measured by ultrasonography
Postoperative opioid analgesic consumption (morphine)
milligram
Postoperative opioid analgesic consumption (morphine)
milligram
Postoperative opioid analgesic consumption (morphine)
milligram
Postoperative opioid analgesic consumption (morphine)
milligram
Full Information
NCT ID
NCT05442814
First Posted
April 18, 2022
Last Updated
June 2, 2023
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT05442814
Brief Title
Anterior and Posterior Approaches of Suprascapular Nerve Block
Official Title
Comparison of Anterior and Posterior Approaches of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Postoperative Pain, Diaphragmatic Paralysis, Subomohyoid Suprascapular Nerve Block, Anterior Suprascapular Nerve Block, Suprascapular Nerve Block
Keywords
Shoulder pain, Nerve Block, Diaphragmatic paralysis, Postoperative pain, Suprascapular block, Subomohyoid suprascapular block, Posterior Suprascapular block, Anterior Suprascapular block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participant with anterior suprascapular block ,group 1 participant with posterior suprascapular block, group 2
Masking
Outcomes Assessor
Masking Description
sealed envelope
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posterior suprascapular block
Arm Type
Active Comparator
Arm Description
Suprascapular block performed by posterior approach
Arm Title
Anterior suprascapular block
Arm Type
Active Comparator
Arm Description
Suprascapular block performed by anterior approach
Intervention Type
Procedure
Intervention Name(s)
Posterior suprascapular block
Intervention Description
Diaphragmatic thickness fraction will be evaluated in the participant underwent suprascapular block performed by posterior approach
Intervention Type
Procedure
Intervention Name(s)
Anterior suprascapular block
Intervention Description
Diaphragmatic thickness fraction will be evaluated in the participant underwent suprascapular block performed by anterior approach
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Visual analog scale (1-10): 1= no pain, 10= the worst pain ever feel.
Time Frame
The first postoperative 30 minutes
Title
Pain rating
Description
Measured by VAS ( Visual analog scale).
Time Frame
Postoperative 4 hours
Title
Pain Rating
Description
Measured by VAS ( Visual analog scale).
Time Frame
Postoperative 6 hours
Title
Pain Rating
Description
Measured by VAS ( Visual analog scale).
Time Frame
Postoperative 12 hours
Title
Pain Rating
Description
Measured by VAS ( Visual analog scale).
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Diaphragmatic movements
Description
Ratio of diaphragm thickness in end-inspiration and end-expiration measured by ultrasonography
Time Frame
Baseline (Before the block performed) and 30 minutes after the end of surgery
Title
Postoperative opioid analgesic consumption (morphine)
Description
milligram
Time Frame
postoperative 4 hours
Title
Postoperative opioid analgesic consumption (morphine)
Description
milligram
Time Frame
postoperative 6 hours
Title
Postoperative opioid analgesic consumption (morphine)
Description
milligram
Time Frame
postoperative 12 hours
Title
Postoperative opioid analgesic consumption (morphine)
Description
milligram
Time Frame
postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Girgin Dinç, MD
Organizational Affiliation
İstanbul Medeniyet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
study not yet completed
Learn more about this trial
Anterior and Posterior Approaches of Suprascapular Nerve Block
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