- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07601529
Comparison of Anterior Sciatic Nerve Block and Adductor Magnus Muscle Plane Block for Anterior Cruciate Ligament Surgery
Comparison of Anterior Sciatic Nerve Block and Adductor Magnus Muscle Plane Block Added to Adductor Canal Block in Patients Undergoing Anterior Cruciate Ligament Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This single-center, prospective, randomized clinical trial included 90 patients aged 18-45 years with ASA physical status I-II who underwent arthroscopic anterior cruciate ligament reconstruction under spinal anesthesia. Patients were randomly allocated into three groups to receive either adductor canal block alone (Group C), adductor canal block combined with anterior sciatic nerve block (Group ASB), or adductor canal block combined with adductor magnus muscle plane block (Group AMB). Randomization was performed using a computer-generated sequence with concealed allocation through sealed opaque envelopes. Although the anesthesiologist performing the blocks was aware of group allocation, all postoperative assessments were conducted by an independent blinded investigator. All regional blocks were ultrasound-guided and performed preoperatively by the same experienced anesthesiologist using standardized techniques and local anesthetic volumes. Procedural characteristics, including block performance time, needle visibility, needle passes, and sonographic visibility of target structures, were systematically recorded. Sensory blockade was assessed at predefined intervals using cold-warm discrimination tests across multiple nerve distributions.
All patients received standardized spinal anesthesia with hyperbaric bupivacaine, as well as a multimodal postoperative analgesic regimen including intravenous paracetamol, dexketoprofen, and fentanyl-based patient-controlled analgesia. Postoperative pain scores at rest and during movement were evaluated at multiple time points during the first 24 hours, while cumulative fentanyl consumption, time to first PCA demand, and rescue analgesic requirements were recorded. Opioid-related adverse events, including nausea, vomiting, constipation, pruritus, dry mouth, and urinary retention, were also documented. In addition, postoperative motor function of the tibialis anterior and quadriceps femoris muscles was assessed using a three-point qualitative motor scale at predefined postoperative intervals up to 48 hours.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Erzurum, Tyrkiet (Türkiye), 25100
- Ataturk Universtiy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Anesthesiologists (ASA) physical status I-II,
- Scheduled for arthroscopic anterior cruciate ligament reconstruction
Exclusion Criteria:
- cardiovascular disease,
- hepatic dysfunction,
- coagulopathy or current use of anticoagulant therapy,
- inability to cooperate,
- known allergy to any of the study medications,
- refusal to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Adductor Canal Block
Participants in this arm will receive an ultrasound-guided adductor canal block using 20 mL of 0.25% bupivacaine.
Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments.
All patients will receive standardized spinal anesthesia and perioperative analgesia.
|
Ultrasound transducer was placed perpendicular to the thigh to visualize the sartorius muscle, femoral artery and vein, and the adductor canal.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced in-plane from lateral to medial toward the adductor canal.
After confirming correct needle tip placement with 2 mL of 0.9% NaCl solution, 20 mL of 0.25% bupivacaine was administered.
Andre navne:
|
|
Aktiv komparator: Adductor Canal + Anterior Sciatic nerve block
Participants in this arm will receive an ultrasound-guided anterior sciatic nerve block (20 mL of 0.25% bupivacaine) and adductor canal block (20 mL of 0.25% bupivacaine).
Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments.
All patients will receive standardized spinal anesthesia and perioperative analgesia.
|
Ultrasound transducer was placed perpendicular to the thigh to visualize the sartorius muscle, femoral artery and vein, and the adductor canal.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced in-plane from lateral to medial toward the adductor canal.
After confirming correct needle tip placement with 2 mL of 0.9% NaCl solution, 20 mL of 0.25% bupivacaine was administered.
Andre navne:
An ultrasound transducer was placed perpendicular to the anterior thigh.
The sartorius muscle, femoral artery and vein, adductor longus muscle, adductor magnus muscle, and the sciatic nerve were identified.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced toward the sciatic nerve under ultrasound guidance.
Nerve stimulation was applied, and an appropriate motor response in the sciatic nerve distribution was obtained at 0.2-0.5 mA.
After injection of 2 mL of 0.9% saline and visualization of perineural spread to confirm correct needle placement, 20 mL of 0.25% bupivacaine was administered.
Andre navne:
|
|
Aktiv komparator: Adductor Canal + Adductor magnus plane block
Participants in this arm will receive an ultrasound-guided adductor magnus plane block (20 mL of 0.25% bupivacaine) and an adductor canal block (20 mL of 0.25% bupivacaine).
Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments.
All patients will receive standardized spinal anesthesia and perioperative analgesia.
|
Ultrasound transducer was placed perpendicular to the thigh to visualize the sartorius muscle, femoral artery and vein, and the adductor canal.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced in-plane from lateral to medial toward the adductor canal.
After confirming correct needle tip placement with 2 mL of 0.9% NaCl solution, 20 mL of 0.25% bupivacaine was administered.
Andre navne:
An ultrasound transducer was placed perpendicular to the thigh to visualise the sartorius muscle, femoral artery and vein, adductor longus, and the underlying adductor magnus muscle.
Following infiltration of the skin and subcutaneous tissue with 2% lidocaine, a 22-gauge, 10-cm echogenic needle was advanced until the posterior fascia of the adductor magnus muscle was penetrated.
After injection of 2 mL of 0.9% NaCl solution, correct needle placement was confirmed by observing fluid spread beneath the posterior surface of the adductor magnus muscle.
Subsequently, 20 mL of 0.25% bupivacaine was administered.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Opioid consumption
Tidsramme: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour
|
Postoperative opioid consumption
|
0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Scores (VAS) at Rest and During Movement
Tidsramme: PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours
|
Pain intensity will be evaluated using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain).
Assessments will be performed at rest and during movement at predefined postoperative time points.
|
PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours
|
|
Adverse Effects
Tidsramme: up to 24 hours
|
Opioid-Related Adverse Effects
|
up to 24 hours
|
|
Evaluation of Nerve Blockade after Nerve Block Application
Tidsramme: 5., 10., 15., 20., 30., and 45. minutes
|
Post-block sensory assessment was performed at predefined time intervals using a cold-warm discrimination test. Sensory evaluation was conducted at the plantar surface of the foot for the tibial nerve, the dorsal surface of the foot for the superficial peroneal nerve, the posterolateral aspect of the leg for the sural nerve, the posterior aspect of the thigh for the posterior femoral cutaneous nerve, and at the medial malleolus for the saphenous nerve. |
5., 10., 15., 20., 30., and 45. minutes
|
|
Quadriceps and Anterior Tibialis Muscle Strength
Tidsramme: 4th hours, 8th hours, 12th hours, 24th hours, 48th hours
|
Muscle strength will be assessed using standardized manual muscle testing (paralysis/paresis/normal) for quadriceps and anterior tibialis muscles.
|
4th hours, 8th hours, 12th hours, 24th hours, 48th hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Samet Kapakin, Professor, Ataturk University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Nøgleord
Andre undersøgelses-id-numre
- B.30.2.ATA.0.01.00/761
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 ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
-
Samsun UniversityRekrutteringAnterior Cruciate Ligament (ACL)Tyrkiet (Türkiye)
-
Nantes University HospitalRekrutteringAnterior Cruciate Ligament (ACL)Frankrig
-
University Hospital, BrestIkke rekrutterer endnuAnterior Cruciate Ligament Rupture med LigamentoplastikFrankrig
-
Ahmed Mohamed Mahmoud Abdelaziz KhalilCairo UniversityAfsluttetBlodstrømsbegrænsende terapi | Anterior Cruciate Ligament (ACL)Egypten
-
Centre Hospitalier Universitaire, AmiensAfsluttetRekonstruktion | Anterior Cruciate Ligament (ACL) | SoftwareFrankrig
-
Rush University Medical CenterRekrutteringAnterior Cruciate Ligament (ACL) genopbygningskirurgiForenede Stater
-
Nigde Omer Halisdemir UniversityAfsluttetPostural stabilitet | Anterior Cruciate Ligament (ACL)Tyrkiet (Türkiye)
-
Hacettepe UniversityRekrutteringRehabilitering af forreste korsbånd | Styrkeresultater | Anterior Cruciate Ligament (ACL) genopbygningskirurgiTyrkiet (Türkiye)
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRekrutteringACL - Anterior Cruciate Ligament DeficiencyFrankrig
-
GCS Ramsay Santé pour l'Enseignement et la RechercheRekrutteringACL - Anterior Cruciate Ligament DeficiencyFrankrig
Kliniske forsøg med Adductor canal block
-
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