- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07640464
Diaphragmatic Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block (ICB-SNB)
Evaluation of the Effects of Combined Infraclavicular Brachial Plexus Block and Suprascapular Nerve Block on the Diaphragm in Arthroscopic Shoulder Surgery
Study Overview
Status
Detailed Description
This prospective observational study was conducted to evaluate the effects of combined infraclavicular brachial plexus block and anterior suprascapular nerve block on diaphragmatic excursion in patients undergoing elective arthroscopic shoulder surgery.
Patients scheduled for arthroscopic shoulder surgery under regional anesthesia were enrolled in the study. Prior to block administration, baseline diaphragmatic excursion was assessed using ultrasonography during both normal and deep breathing. Each measurement was repeated three times, and the mean value was recorded. The same measurements were repeated 30 minutes after completion of the block procedures using an identical protocol.
The percentage change in diaphragmatic excursion between baseline and post-block measurements was calculated for both normal and deep breathing. Hemidiaphragmatic paralysis was categorized according to the degree of reduction in diaphragmatic excursion as absent (≤25% reduction), partial (25.1-74.9% reduction), or complete (≥75% reduction).
All nerve blocks were performed under ultrasound guidance by anesthesiologists experienced in regional anesthesia techniques. The infraclavicular brachial plexus block was performed using 15 mL of 0.5% bupivacaine deposited around the posterior cord and 8 mL of 0.5% bupivacaine around the lateral cord. The anterior suprascapular nerve block was performed with 7 mL of 0.5% bupivacaine. In addition, arthroscopic portal sites were infiltrated with 10 mL of 0.2% bupivacaine to provide supplementary analgesia.
All patients received intravenous midazolam (2 mg) and paracetamol (1 g) during the intraoperative period. Additional analgesic or sedative medication was administered when required according to clinical conditions and surgical needs. Block performance time, requirement for supplemental analgesia or sedation, and any block-related adverse events were recorded.
The primary outcome measure was the change in diaphragmatic excursion measured by ultrasonography 30 minutes after block administration. Secondary outcome measures included the incidence and severity of hemidiaphragmatic paralysis, block performance time, duration of postoperative analgesia, need for additional intraoperative analgesia or sedation, time to first analgesic requirement, patient and surgeon satisfaction, block-related complications, and conversion to general anesthesia.
The study was designed to investigate whether the combination of infraclavicular brachial plexus block and anterior suprascapular nerve block could provide effective anesthesia and analgesia for arthroscopic shoulder surgery while minimizing impairment of diaphragmatic function and reducing the incidence of clinically significant hemidiaphragmatic paralysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06500
- Gazi University Faculty of Medicine Hospital
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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 aged 18-80 years.
- ASA physical status I-III.
- Scheduled for elective arthroscopic shoulder surgery.
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to undergo peripheral nerve block.
- Pre-existing peripheral neuropathy.
- Known pulmonary, hepatic, or renal disease.
- Allergy to local anesthetics.
- Infection at the block site.
- Pre-existing neurological deficit.
- Body mass index (BMI) > 40 kg/m².
- Coagulopathy.
- Sepsis.
Previous surgery at the planned block site.
- Major psychiatric disorders.
- Inability to complete diaphragmatic ultrasonographic assessment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients Undergoing Arthroscopic Shoulder Surgery
Patients undergoing arthroscopic shoulder surgery who received a combined infraclavicular brachial plexus block and anterior suprascapular nerve block.
Diaphragmatic excursion was evaluated using ultrasonography before and after block administration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Diaphragmatic Excursion at 30 Minutes After Block Administration
Time Frame: 30 minutes after block administration
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Diaphragmatic excursion measured by ultrasonography during normal and deep breathing before block administration and 30 minutes after block administration.
The percentage change from baseline was calculated.
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30 minutes after block administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Hemidiaphragmatic Paralysis
Time Frame: 30 minutes after block administration
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Presence of hemidiaphragmatic paralysis determined by ultrasonographic assessment of diaphragmatic excursion.
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30 minutes after block administration
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Degree of Hemidiaphragmatic Paralysis
Time Frame: 30 minutes after block administration
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Hemidiaphragmatic paralysis classified as absent (≤25% reduction), partial (25.1-74.9%
reduction), or complete (≥75% reduction)
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30 minutes after block administration
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Block Performance Time
Time Frame: From needle insertion to completion of the block procedure
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Time required to complete the combined infraclavicular brachial plexus block and anterior suprascapular nerve block.
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From needle insertion to completion of the block procedure
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Additional Intraoperative Analgesia Requirement
Time Frame: From surgical incision to the end of surgery
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Requirement for supplemental analgesic medication during surgery.
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From surgical incision to the end of surgery
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Time to First Analgesic Requirement
Time Frame: Up to 24 hours after surgery
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Time from completion of the block procedure to the first postoperative analgesic request.
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Up to 24 hours after surgery
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Block-Related Complications
Time Frame: From block administration until 24 hours after surgery
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Incidence of block-related adverse events including Horner syndrome, hoarseness, nausea/vomiting, and hemodynamic complications.
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From block administration until 24 hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: IRFAN GUNGOR, MD, Gazi University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2024-GUTF-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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