Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy (ISB-ROOT)
Does the Injection Site of Local Anesthetic Around the C5-C7 Nerve Roots Affect Block Success and Complication Rates During Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients scheduled for elective shoulder arthroscopy under general anesthesia will be randomly assigned to one of two ultrasound-guided interscalene block techniques. In one group, the local anesthetic will be injected between the C5-C7 nerve roots and the anterior scalene muscle. In the other group, the injection will be performed between the C5-C7 nerve roots and the middle scalene muscle. The same local anesthetic solution, volume, and concentration will be used in both groups.
Block success, postoperative pain control, opioid consumption, diaphragmatic movement assessed by ultrasonography, and block-related complications including vascular puncture, Horner syndrome, hoarseness, dyspnea, nausea, vomiting, and prolonged motor block will be recorded and compared between the groups.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hakan Emirkadı, MD
- Telefonnummer: +905322609367
- E-post: hemirkadi@gmail.com
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye), 34668
- Sultan Abdulhamid Han Training and Research Hospital
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Ta kontakt med:
- Hakan drhemirkadi
- Telefonnummer: 05322609367
- E-post: hemirkadi@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Adults aged 18 years or older. ASA physical status I-III. Scheduled for shoulder arthroscopy under general anesthesia with a planned ultrasound-guided interscalene block for postoperative analgesia.
Able to provide written informed consent. Normal coagulation parameters and no antithrombotic therapy. No infection or anatomical abnormality at the injection site. No known allergy to local anesthetics. No contralateral diaphragmatic paralysis or pneumothorax. No dyspnea and adequate pulmonary function.
Exclusion Criteria:
Age younger than 18 years or ASA physical status IV. Antithrombotic therapy or abnormal coagulation parameters. Infection or anatomical abnormality at the injection site. Known allergy to local anesthetics. Contralateral diaphragmatic paralysis or history of pneumothorax. Dyspnea. Refusal to undergo interscalene block.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Anterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle.
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Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia.
Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.
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Eksperimentell: Posterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle.
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Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia.
Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Analgesic Efficacy
Tidsramme: 12 hours after surgery
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Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
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12 hours after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time to First Rescue Analgesic
Tidsramme: 12 hours after surgery
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Time from the end of surgery to first rescue analgesic administration.
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12 hours after surgery
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Hemidiaphragmatic Paralysis
Tidsramme: Before block and 2 hours after surgery
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Presence of ipsilateral hemidiaphragmatic paralysis assessed by ultrasonography.
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Before block and 2 hours after surgery
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Block-Related Complications
Tidsramme: During block placement and within 12 hours after surgery
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Incidence of vascular puncture, intraneural injection, Horner syndrome, dyspnea, hoarseness, nausea, vomiting, recurrent laryngeal nerve block, stellate ganglion block, and prolonged motor block.
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During block placement and within 12 hours after surgery
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Block Duration
Tidsramme: 12 hours after surgery
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Duration of sensory and motor block recorded during postoperative follow-up.
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12 hours after surgery
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Tuna Erturk, MD, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 21-19
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