- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Erzurum, Turchia (Türkiye), 25100
- Ataturk Universtiy
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
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.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Opioid consumption
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Scores (VAS) at Rest and During Movement
Lasso di tempo: 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
Lasso di tempo: up to 24 hours
|
Opioid-Related Adverse Effects
|
up to 24 hours
|
|
Evaluation of Nerve Blockade after Nerve Block Application
Lasso di tempo: 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
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Quadriceps and Anterior Tibialis Muscle Strength
Lasso di tempo: 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.
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4th hours, 8th hours, 12th hours, 24th hours, 48th hours
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Samet Kapakin, Professor, Ataturk University
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- B.30.2.ATA.0.01.00/761
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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