- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Atakan Sezgi
- Telefonnummer: 00905323327000
- E-mail: kansezgi@gmail.com
Undersøgelse Kontakt Backup
- Navn: Musa Zengin
- Telefonnummer: 00905307716235
- E-mail: musazengin@gmail.com
Studiesteder
-
-
-
Ankara, Tyrkiet (Türkiye)
- Rekruttering
- Ankara Etlik City Hospital
-
Kontakt:
- Musa Zengin, Associate Professor
- Telefonnummer: 00905307716235
- E-mail: musazengin@gmail.com
-
Kontakt:
- Atakan Sezgi, M.D.
- Telefonnummer: 00905323327000
- E-mail: kansezgi@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neuroadfærdsmæssige manifestationer
- Perceptuelle forstyrrelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Agnosia
- Undersøgelsesteknikker
- Epidemiologisk forskningsdesign
- Epidemiologiske metoder
- Forskningsdesign
- Metoder
- Kontrolgrupper
Andre undersøgelses-id-numre
- AEŞH-EK-2026-071
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Smertebehandling
-
University of Texas at AustinRekruttering
-
Akdeniz University HospitalAfsluttetEmergency Airway Management | Gastric Inflation Risk During Bag-Valve-Mask Ventilation | Breathing EmergencyTyrkiet (Türkiye)
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityAktiv, ikke rekrutterende
-
Hager Montaser Sayed BedeerIkke rekrutterer endnuBagruller Assesment | Tilbage Rolls Management
-
Emine KaracanIkke rekrutterer endnuLivskvalitet | Menopausale symptomer | Overgangsalderen Symptom ManagementTyrkiet (Türkiye)
-
University Hospital, GrenobleUkendtHealth Care Quality Management (ingen betingelse).Frankrig
-
Atom Therapeutics Co., LtdRekrutteringASCVD | ASCVD Management | Aterosklerose Hjerte-kar-sygdomKina, Forenede Stater, Australien
-
Becton, Dickinson and CompanyAfsluttetKateterrelateret komplikation | Vascular Access Site Management | DesinfektionshætteBelgien, Østrig, Spanien, Italien
-
Mayo ClinicTilmelding efter invitationMenopausale symptomer | Overgangsalderen Symptom ManagementForenede Stater
-
Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
Kliniske forsøg med Adductor Canal Block Group
-
Ain Shams UniversityAfsluttet
-
Karaman Training and Research HospitalAfsluttetSlidgigt i knæetKalkun
-
Tanta UniversityAfsluttetTotal knæarthroplastik | Postoperativ analgesi | Adduktorkanalblok | Femoral nerveblok | Dobbelt understartet blokEgypten
-
Ain Shams UniversityIkke rekrutterer endnuFunktionel gendannelse | Adduktorkanalblok | Total knæudskiftningskirurgi
-
Asklepieion Voulas General HospitalChryssoula Staikou; Aikaterini KalampokiniUkendt
-
Ain Shams UniversityRekrutteringTidsintervallet mellem injektion af blokken og den første redningsanalgesidosis. Postoperativ smertevurdering ved hjælp af NRS-score for smerteEgypten
-
Rasha HamedAfsluttet
-
TC Erciyes UniversityRekrutteringKnæarthroplastik, i altTyrkiet (Türkiye)
-
Medical University of South CarolinaAfsluttet
-
Başakşehir Çam & Sakura City HospitalRekrutteringOpioidbrug | Smerter postoperativt | Artroskopiske knæoperationerKalkun