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?
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hakan Emirkadı, MD
- Telefonnummer: +905322609367
- E-post: hemirkadi@gmail.com
Studieorter
-
-
Istanbul
-
Istanbul, Istanbul, Turkiet (Türkiye), 34668
- Sultan Abdulhamid Han Training and Research Hospital
-
Kontakt:
- Hakan drhemirkadi
- Telefonnummer: 05322609367
- E-post: hemirkadi@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Anterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle.
|
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.
|
|
Experimentell: Posterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Analgesic Efficacy
Tidsram: 12 hours after surgery
|
Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
|
12 hours after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to First Rescue Analgesic
Tidsram: 12 hours after surgery
|
Time from the end of surgery to first rescue analgesic administration.
|
12 hours after surgery
|
|
Hemidiaphragmatic Paralysis
Tidsram: Before block and 2 hours after surgery
|
Presence of ipsilateral hemidiaphragmatic paralysis assessed by ultrasonography.
|
Before block and 2 hours after surgery
|
|
Block-Related Complications
Tidsram: During block placement and within 12 hours after surgery
|
Incidence of vascular puncture, intraneural injection, Horner syndrome, dyspnea, hoarseness, nausea, vomiting, recurrent laryngeal nerve block, stellate ganglion block, and prolonged motor block.
|
During block placement and within 12 hours after surgery
|
|
Block Duration
Tidsram: 12 hours after surgery
|
Duration of sensory and motor block recorded during postoperative follow-up.
|
12 hours after surgery
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Tuna Erturk, MD, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 21-19
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .