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?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hakan Emirkadı, MD
- Telefoonnummer: +905322609367
- E-mail: hemirkadi@gmail.com
Studie Locaties
-
-
Istanbul
-
Istanbul, Istanbul, Turkije (Türkiye), 34668
- Sultan Abdulhamid Han Training and Research Hospital
-
Contact:
- Hakan drhemirkadi
- Telefoonnummer: 05322609367
- E-mail: hemirkadi@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative Analgesic Efficacy
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to First Rescue Analgesic
Tijdsspanne: 12 hours after surgery
|
Time from the end of surgery to first rescue analgesic administration.
|
12 hours after surgery
|
|
Hemidiaphragmatic Paralysis
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 12 hours after surgery
|
Duration of sensory and motor block recorded during postoperative follow-up.
|
12 hours after surgery
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Tuna Erturk, MD, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 21-19
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .