- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07683078
Effect of Adding Vastus Medialis Nerve Block to Adductor Canal Block After Anterior Cruciate Ligament Reconstruction (VAMA)
Effect of Adding Vastus Medialis Nerve Block to Adductor Canal Block on Postoperative Analgesia Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
Anterior cruciate ligament (ACL) reconstruction is frequently associated with moderate to severe postoperative pain, which can delay mobilization and rehabilitation. The adductor canal block (ACB) is widely used for postoperative pain management because it provides effective analgesia while preserving quadriceps muscle strength. However, pain originating from the medial aspect of the knee may not be adequately controlled with ACB alone because the nerve to the vastus medialis may not be consistently anesthetized.
This prospective randomized controlled trial evaluates whether adding a vastus medialis nerve block (VMNB) to a standard adductor canal block improves postoperative pain control in patients undergoing elective arthroscopic ACL reconstruction. Participants are randomly assigned to receive either ACB alone or ACB combined with VMNB before surgery, while all patients receive the same standardized general anesthesia, surgical technique, and postoperative analgesic regimen.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, time to first mobilization, length of hospital stay, and block-related complications. The results of this study may help determine whether the addition of a vastus medialis nerve block provides clinically meaningful benefits and may contribute to improving postoperative pain management following ACL reconstruction.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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ABD Dışında
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Istanbul, ABD Dışında, Tyrkia (Türkiye), 34400
- SBU Bagcilar Education and Training Hospital
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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 to 65 years.
- Scheduled for elective primary arthroscopic anterior cruciate ligament (ACL) reconstruction.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Ability to provide written informed consent.
Exclusion Criteria:
- Previous surgery on the ipsilateral knee.
- Bilateral knee surgery.
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia.
- Peripheral neuropathy or neuromuscular disease.
- Local infection at the block injection site.
- Known allergy or hypersensitivity to amide local anesthetics.
- Contraindication to regional anesthesia.
- Refusal to participate in the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Adductor Canal Block
Participants received an ultrasound-guided adductor canal block before elective arthroscopic anterior cruciate ligament reconstruction.
All participants received standardized general anesthesia and postoperative analgesic management.
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An ultrasound-guided adductor canal block was performed before induction of general anesthesia using 15-20 mL of 0.25% bupivacaine as part of the multimodal analgesia protocol for anterior cruciate ligament reconstruction.
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Aktiv komparator: Adductor Canal Block Plus Vastus Medialis Nerve Block
Participants received an ultrasound-guided adductor canal block combined with an ultrasound-guided vastus medialis nerve block before elective arthroscopic anterior cruciate ligament reconstruction.
All participants received standardized general anesthesia and postoperative analgesic management.
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An ultrasound-guided adductor canal block was performed before induction of general anesthesia using 15-20 mL of 0.25% bupivacaine as part of the multimodal analgesia protocol for anterior cruciate ligament reconstruction.
An ultrasound-guided vastus medialis nerve block was performed before induction of general anesthesia using 5-10 mL of 0.25% bupivacaine in addition to the adductor canal block.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Intensity
Tidsramme: 24 hours after surgery
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Postoperative pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS) at rest at 1, 6, 12, and 24 hours after surgery.
VAS scores range from 0 (no pain) to 10 (worst imaginable pain).
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24 hours after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Opioid Consumption
Tidsramme: 24 hours after surgery
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Total opioid consumption during the first 24 postoperative hours will be calculated as intravenous morphine equivalent dose (mg).
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24 hours after surgery
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Time to First Mobilization
Tidsramme: 24 hours after surgery
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Time from completion of surgery to the patient's first successful ambulation, recorded in hours.
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24 hours after surgery
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Length of Hospital Stay
Tidsramme: 24 hours after surgery
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Length of postoperative hospital stay measured in hours from the end of surgery until hospital discharge.
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24 hours after surgery
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- Smerte
- Nevrologiske manifestasjoner
- Sår og skader
- Postoperative komplikasjoner
- Patologiske prosesser
- Beinskader
- Kneskader
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Fremre korsbåndskader
- Smerter, postoperativt
- Sosioøkonomiske faktorer
- Befolkningskarakteristikker
- Demografi
- Familieegenskaper
- Sivilstand
- Enkeltperson
Andre studie-ID-numre
- 681433
Legemiddel- og utstyrsinformasjon, studiedokumenter
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