- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429669
Comparative Analgesia and Respiratory Effects of Shoulder Blocks
Analgesic Efficacy and Respiratory Effects of Interscalene, Anterior Suprascapular, and Pericapsular Nerve Group Blocks in Shoulder Arthroscopy
Interscalene block is widely accepted as the gold-standard regional analgesic technique for pain control after arthroscopic shoulder surgery. However, because this block is performed at the level of the brachial plexus roots, it may be associated with adverse effects such as phrenic nerve blockade and subsequent diaphragmatic dysfunction. These limitations have prompted the search for alternative regional anesthesia techniques that can provide effective postoperative analgesia while preserving respiratory function.
The anterior suprascapular block, which covers a broad dermatomal distribution of the shoulder region, has been shown in some studies to provide sufficient analgesia as a standalone technique. In addition, the pericapsular nerve group (PENG) block of the shoulder-applied around the anterior capsule and performed at a distance from critical neurovascular structures that may lead to serious complications-may represent another potential analgesic option following arthroscopic shoulder procedures.
Therefore, this study aims to evaluate alternative regional block techniques in comparison with the interscalene block and to contribute to the identification of an optimal analgesic strategy after arthroscopic shoulder surgery.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Yenimahalle, Ankara, Turkey (Türkiye), 06170
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Musa Zengin, Associate Professor
- Phone Number: 00905307716235
- Email: musazengin@gmail.com
-
Contact:
- Muammer Bulut, MD
- Phone Number: 00905545839533
- Email: muammerblt8@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with ASA scores I-II-III
- Patients scheduled for elective arthroscopic shoulder surgery
- Patients who have been informed about the study and have given written consent will be included.
Exclusion Criteria:
- Those with a known allergy to local anesthetics
- Those with an infection at the application site
- Those with a severe coagulopathy disorder or anticoagulant use
- Those with contralateral phrenic nerve palsy or a serious pulmonary diagnosis
- Those with a history of chronic opioid use or neuropathic pain
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interscalene block
In the preoperative period, 10 mL of 0.25% bupivacaine will be injected between C5 and C6 using an in-plane technique guided by a linear ultrasound (US) probe.
|
Interscalene block will be performed, under US guidance, before the surgical operation, and when the patient is placed in the supine position.
|
|
Active Comparator: Anterior suprascapular block
A linear ultrasound probe will be positioned in the supraclavicular fossa, parallel to the clavicle.
The suprascapular nerve will be identified as a hyperechoic oval structure deep to the omohyoid muscle and posterior-lateral to the brachial plexus.
10 mL of local anesthetic will be injected under the omohyoid muscle, around the suprascapular nerve.
|
Anterior suprascapular block will be performed, under US guidance, before the surgical operation, and when the patient is placed in the supine position.
|
|
Active Comparator: Pericapsular nerve group (PENG) block
A linear ultrasound probe will be placed sagittally, near the axillary region, just below the coracoid process.
The subscapularis muscle and its tendon will be visualized.
The target area is the space between the deep fascia of the subscapularis muscle and the anterior surface of the shoulder joint capsule.
The needle will pass the subscapularis muscle and be guided into the plane between the capsule and the muscle, where 20 mL of local anesthetic will be dispensed to block the articular branches innervating the capsule.
|
Pericapsular nerve group (PENG) block will be performed, under US guidance, before the surgical operation, and when the patient is placed in the supine position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores
Time Frame: First hour after the surgery
|
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain) at the first postoperative hour.
|
First hour after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores
Time Frame: First 24 hours after surgery
|
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain).
Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.
|
First 24 hours after surgery
|
|
Forced vital capacity (FVC) (volume)
Time Frame: Perioperative period
|
Forced vital capacity (FVC) (volume) will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1, 12, and 24 hours.
|
Perioperative period
|
|
Forced expiratory flow in 1 s (FEV1) (volume)
Time Frame: Perioperative period
|
Forced expiratory flow in 1 s (FEV1) (volume) will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1, 12, and 24 hours.
|
Perioperative period
|
|
FEV1/FVC
Time Frame: Perioperative period
|
FEV1/FVC will be evaluated during the perioperative period.
Measurements will be performed before block administration (baseline), at 30 minutes after the block, and at postoperative 1, 12, and 24 hours.
|
Perioperative period
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK-2026-020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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