- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Ankara
-
Ankara, Ankara, Turkki (Türkiye), 06500
- Gazi University Faculty of Medicine Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Diaphragmatic Excursion at 30 Minutes After Block Administration
Aikaikkuna: 30 minutes after block administration
|
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.
|
30 minutes after block administration
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Incidence of Hemidiaphragmatic Paralysis
Aikaikkuna: 30 minutes after block administration
|
Presence of hemidiaphragmatic paralysis determined by ultrasonographic assessment of diaphragmatic excursion.
|
30 minutes after block administration
|
|
Degree of Hemidiaphragmatic Paralysis
Aikaikkuna: 30 minutes after block administration
|
Hemidiaphragmatic paralysis classified as absent (≤25% reduction), partial (25.1-74.9%
reduction), or complete (≥75% reduction)
|
30 minutes after block administration
|
|
Block Performance Time
Aikaikkuna: From needle insertion to completion of the block procedure
|
Time required to complete the combined infraclavicular brachial plexus block and anterior suprascapular nerve block.
|
From needle insertion to completion of the block procedure
|
|
Additional Intraoperative Analgesia Requirement
Aikaikkuna: From surgical incision to the end of surgery
|
Requirement for supplemental analgesic medication during surgery.
|
From surgical incision to the end of surgery
|
|
Time to First Analgesic Requirement
Aikaikkuna: Up to 24 hours after surgery
|
Time from completion of the block procedure to the first postoperative analgesic request.
|
Up to 24 hours after surgery
|
|
Block-Related Complications
Aikaikkuna: From block administration until 24 hours after surgery
|
Incidence of block-related adverse events including Horner syndrome, hoarseness, nausea/vomiting, and hemodynamic complications.
|
From block administration until 24 hours after surgery
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: IRFAN GUNGOR, MD, Gazi University Faculty of Medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 2024-GUTF-028
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .