- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07483814
Comparison of Postoperative Analgesic Efficacy of Interscalene and Suprascapular Blocks Used in Arthroscopic Shoulder Surgery
Comparison of the Analgesic Effects and Side Effects of Interscalene and Suprascapular Blocks for Pain Control Following Arthroscopic Shoulder Surgery
The Importance of Postoperative Analgesia in Shoulder Surgery
Shoulder surgery is an orthopedic procedure that can be performed either through open surgery or arthroscopically. Pain following shoulder surgery can lead to adverse outcomes such as decreased functional status, increased consumption of narcotic analgesics, and the development of chronic pain.
Therefore, achieving optimal postoperative shoulder analgesia is important not only for patient comfort and satisfaction but also for promoting functional recovery, preventing chronic pain, and reducing the need for narcotic analgesics. Additionally, minimizing the side effects associated with nerve block techniques used for analgesia is crucial for the overall success of the treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The innervation of the shoulder joint is provided by the axillary, musculocutaneous, subscapular, and suprascapular nerves, all of which originate from the brachial plexus. The suprascapular nerve passes through the suprascapular notch on the superior border of the scapula and supplies motor branches to the rotator cuff muscles. Suprascapular nerve block is widely used in the management of shoulder pain.
Regional anesthesia techniques are among the most effective methods for postoperative analgesia. Peripheral nerve blocks, a subtype of regional anesthesia, are particularly suitable for postoperative pain control in shoulder surgeries due to their ability to provide long-lasting and effective analgesia, reduce opioid requirements and related side effects or dependency, and facilitate recovery by promoting early functional restoration.Interscalene brachial plexus block (ISB) is commonly used for analgesia in shoulder surgery and is considered the gold standard technique. However, ISB also blocks the phrenic nerve (C3-C5), which may result in ipsilateral hemidiaphragmatic paresis (HDP). This can cause respiratory complications, particularly in patients with preexisting pulmonary disease, obstructive sleep apnea, or morbid obesity.
The suprascapular nerve block (SSB), applied at a more distal level of the brachial plexus, preserves the phrenic nerve and thus minimizes the respiratory side effects associated with ISB.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Efeler
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Aydin, Efeler, Turkey (Türkiye), 09010
- Adnan menderesüniversite Hastanesi
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who have provided written informed consent
- Patients over 18 years of age scheduled for elective shoulder arthroscopy
- Patients classified as ASA I-II
- Patients undergoing general anesthesia
Exclusion Criteria:
- Patients undergoing shoulder surgery other than arthroscopic procedures (e.g., revision or open surgery)
- Patients with pre-existing respiratory, cardiac, renal, neurological, or hepatic diseases
- Presence of neuropathy affecting the brachial plexus
- Contraindications to peripheral nerve block (e.g., coagulopathy)
- Known allergy to local anesthetics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suprascapular block
For Group I, after the patients were positioned in the sitting posture, reference points were identified based on anatomical landmarks, including the scapular spine and the acromion.
A linear ultrasound probe (13-6 MHz) was used to guide the procedure, targeting the suprascapular notch.
Under sterile conditions, a 22-gauge × 100 mm needle (Braun® Stimuplex) was advanced, and following negative aspiration, 15 mL of 0.5% bupivacaine was injected.
|
In the postoperative recovery room, patients with a Numeric Rating Scale (NRS) score of 4 or higher received 100 mg of intravenous tramadol as rescue analgesia.
In addition, both groups routinely received 1 g of intravenous paracetamol every 6 hours during their stay in the ward.
During ward follow-up, if the NRS score was 4 or higher, 100 mg of intravenous tramadol was administered as needed.
|
|
Interscalene block
For Group II, patients were positioned in the supine or semi-sitting position with the head turned to the contralateral side to facilitate access to the lateral aspect of the neck.
Following antiseptic skin preparation, a high-frequency linear ultrasound probe (6-13 MHz) was placed transversely on the lateral neck.
The C5-C7 nerve roots were identified as hyperechoic structures located between the anterior and middle scalene muscles.
Using an in-plane ultrasound-guided approach, a 22-gauge, 50-100 mm nerve block needle was advanced into the interscalene groove.
After confirming negative aspiration, 15 mL of 0.5% bupivacaine was administered around the nerve roots.
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In the postoperative recovery room, patients with a Numeric Rating Scale (NRS) score of 4 or higher received 100 mg of intravenous tramadol as rescue analgesia.
In addition, both groups routinely received 1 g of intravenous paracetamol every 6 hours during their stay in the ward.
During ward follow-up, if the NRS score was 4 or higher, 100 mg of intravenous tramadol was administered as needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The analgesic efficacy of interscalene block (ISB) and suprascapular block (SSB) will be compared in patients undergoing shoulder arthroscopy.
Time Frame: the first 48 hours postoperatively
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It is a pain intensity assessment system based on the patient indicating a point between 0 (no pain) and 10 (unbearable pain) to describe their pain level.
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the first 48 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The development of chronic pain following interscalene block (ISB) and suprascapular block (SSB) will be compared in patients undergoing shoulder arthroscopy.
Time Frame: 3 months postoperatively
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Postoperative chronic pain will be evaluated after 3 months using a numerical rating pain scale: 0 (no pain) to 10 (unbearable pain).
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3 months postoperatively
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The side effects of interscalene block (ISB) and suprascapular block (SSB) will be compared in patients undergoing shoulder arthroscopy.
Time Frame: the first 48 hours postoperatively
|
The number of patients with dyspnea symptoms after suprascapular and interscalene blocks applied after arthroscopic shoulder surgery will be compared.
|
the first 48 hours postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Durali BAYKA
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/12/01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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