- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Ankara
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Ankara, Ankara, Tyrkiet (Türkiye), 06500
- Gazi University Faculty of Medicine Hospital
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Diaphragmatic Excursion at 30 Minutes After Block Administration
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Hemidiaphragmatic Paralysis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: IRFAN GUNGOR, MD, Gazi University Faculty of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2024-GUTF-028
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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