- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07603323
Comparison of Analgesic Effects of ACB Versus ACB Combined With BiFeS Block in Meniscopathy Surgery
Comparison of Analgesic Effects of Adductor Canal Block Versus Adductor Canal Block Combined With BiFeS (Biceps Femoris Short Head) Block in Meniscopathy Surgery
Meniscopathy surgeries are commonly associated with moderate postoperative pain, particularly during early mobilization and rehabilitation. Inadequate postoperative analgesia may negatively affect functional recovery, delay ambulation, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing arthroscopic knee procedures.
Adductor canal block (ACB) is a widely used regional anesthesia technique that provides effective analgesia while largely preserving quadriceps muscle strength. However, its limited effect on posterior knee capsule innervation may result in insufficient control of posterior knee pain. Recently, the biceps femoris short head (BiFeS) block has been described as a novel motor-sparing fascial plane block targeting the posterolateral knee capsule and may provide additional analgesic benefit when combined with ACB.
In this study, it was aimed to compare the postoperative analgesic efficacy of adductor canal block alone and adductor canal block combined with BiFeS block in patients undergoing surgery for meniscopathy.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Atakan Sezgi
- Telefonnummer: 00905323327000
- E-post: kansezgi@gmail.com
Studer Kontakt Backup
- Navn: Musa Zengin
- Telefonnummer: 00905307716235
- E-post: musazengin@gmail.com
Studiesteder
-
-
-
Ankara, Tyrkia (Türkiye)
- Rekruttering
- Ankara Etlik City Hospital
-
Ta kontakt med:
- Musa Zengin, Associate Professor
- Telefonnummer: 00905307716235
- E-post: musazengin@gmail.com
-
Ta kontakt med:
- Atakan Sezgi, M.D.
- Telefonnummer: 00905323327000
- E-post: kansezgi@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged 18-65 years
- American Society of Anesthesiologists (ASA) score I-II-III
- Body Mass Index (BMI) between 18-30 kg/m2
Exclusion Criteria:
- Patients under 18 and over 65 years of age
- ASA score IV and above
- Patients with a history of bleeding diathesis
- BMI below 18 or above 30 kg/m2
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Adductor Canal Block Group
After the linear ultrasound probe is placed transversely over the mid-thigh on the side of surgery, the sartorius muscle, femoral artery, vastus medialis muscle, and adductor canal will be identified.
The probe will be adjusted to obtain an optimal short-axis view of the femoral artery beneath the sartorius muscle.
A block needle will then be advanced using an in-plane technique toward the adductor canal.
After negative aspiration, 10 ml of 0.25% bupivacaine will be injected into the fascial plane adjacent to the femoral artery within the adductor canal.
Proper spread of the local anesthetic around the femoral artery and beneath the sartorius muscle will be confirmed by ultrasound imaging.
|
Adductor canal block will be performed on the patients using 10 ml of 0.25% bupivacaine under ultrasound guidance. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. |
|
Aktiv komparator: Adductor Canal Block + BiFeS (Biceps Femoris Short Head) Block Group
First, 10 ml of 0.25% bupivacaine will be injected into the adductor canal, and proper spread of the local anesthetic around the femoral artery and beneath the sartorius muscle will be confirmed by ultrasound imaging.
Subsequently, the biceps femoris short head block will be performed under ultrasound guidance on the same side.
The ultrasound probe will be positioned to identify the short head of the biceps femoris muscle and the lateral femoral cortex at the distal thigh/supracondylar region.
A block needle will be advanced using an in-plane technique toward the fascial plane between the short head of the biceps femoris muscle and the lateral femoral cortex.
After negative aspiration, 20 ml of 0.25% bupivacaine will be injected into this plane.
Adequate spread of the local anesthetic along the interface between the biceps femoris short head and the femur will be confirmed by ultrasound imaging.
|
In the adductor canal block + BiFeS block group, adductor canal block will be performed using 10 ml of 0.25% bupivacaine, followed by BiFeS block using 20 ml of 0.25% bupivacaine under ultrasound guidance, with a total local anesthetic volume of 30 ml. Additionally, in the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia. |
|
Aktiv komparator: Control Group
Participants in the control group will not receive any regional block intervention.
|
In the postoperative period a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Scores
Tidsramme: On the operation day
|
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 100 (worst pain).
Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
|
On the operation day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Postoperative Morphine Consumption During the First 24 Hours After Surgery
Tidsramme: On the operation day
|
Total Postoperative Morphine Consumption During the First 24 Hours After Surgery
|
On the operation day
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AEŞH-EK-2026-071
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .