Continuous Adductor Canal Block (CACB) Combined With İnfiltration Between the Popliteal Artery and Capsule of the Knee (iPACK) Block vs Continuous Adductor Canal Block Alone After Total Knee Arthroplasty
Comparison of the Effects of iPACK Block Combined With Continuous Adductor Canal Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia, Early Mobilization, and Length of Hospital Stay in Total Knee Arthroplasty Cases
This study compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in patients undergoing total knee arthroplasty. This is a prospective, randomized, double-blind study with 54 patients allocated 1:1 into two groups.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Severe postoperative pain occurs in up to 58% of patients after total knee arthroplasty. Peripheral nerve blocks are an effective component of multimodal analgesia, and the continuous adductor canal block (CACB) has become a preferred technique because it provides sensory blockade while sparing motor function of the quadriceps, allowing earlier ambulation compared to femoral nerve block. However, CACB does not address posterior knee pain, which can be targeted by the iPACK (infiltration between the popliteal artery and capsule of the knee) block, a technique that blocks terminal sensory branches of the tibial and peroneal nerves without motor blockade.
In this study, patients scheduled for total knee arthroplasty will be randomized 1:1 (using randomizer.org) to receive either CACB alone (Group 2) or CACB combined with a single-injection iPACK block (Group 1). CACB will be maintained via a perineural catheter connected to a patient-controlled analgesia (PCA) pump delivering 0.1% bupivacaine. Rescue analgesia will be provided with intravenous tramadol (50 mg, max 300 mg/day) when the numeric rating scale (NRS) pain score exceeds 4.
Pain scores (NRS 0-10), total analgesic and opioid consumption, hemodynamic parameters, time to first mobilization (assessed via the Timed Up and Go test), patient satisfaction, and length of hospital stay will be recorded at baseline and at 1, 3, 6, 12, and 24 hours postoperatively by an anesthesiologist blinded to group allocation, different from the anesthesiologist who performed the block.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Muzaffer GENCER, MD
- Numéro de téléphone: 905059436459
- E-mail: dr.m.gencer07@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Furkan TONTU, MD
- Numéro de téléphone: 905465771656
- E-mail: furkantontu@gmail.com
Lieux d'étude
-
-
Istanbul
-
Başakşehir, Istanbul, Turquie (Türkiye), 34480
- Basaksehir Çam Ve Sakura City Hospital, İstanbul, Türkiye
-
Contact:
- Muzaffer GENCER, MD
- Numéro de téléphone: 905059436459
- E-mail: dr.m.gencer07@gmail.com
-
Contact:
- Murat Y MERSİN, MD
- Numéro de téléphone: 905367736432
- E-mail: myasinmersin@gmail.com
-
Chercheur principal:
- Furkan TONTU, MD
-
Sous-enquêteur:
- Muzaffer GENCER, MD
-
Sous-enquêteur:
- Murat Y Mersin, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients of either sex
- Aged 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Voluntary participation
- Fully oriented and able to cooperate with postoperative assessments
Exclusion Criteria:
- ASA physical status IV or V
- Patients who decline to participate
- Pediatric patients
- Active infection at the block site
- Chronic pain or regular analgesic use
- Coagulation disorders
- Inability to cooperate with postoperative pain assessment
- Known allergy to local anesthetics
- Neuropathy or myopathy in the operated extremity
- Revision arthroplasty cases
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1 (CACB + iPACK)
Continuous adductor canal block (catheter, PCA with 0.1% bupivacaine) plus a single-injection iPACK block (0.25% bupivacaine 20 mL) |
Single injection of 0.25% bupivacaine 20 mL between the popliteal artery and posterior knee capsule, performed under ultrasound guidance Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively |
|
Comparateur actif: Group 2 (CACB Alone)
Continuous adductor canal block alone (catheter, PCA with 0.1% bupivacaine) |
Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Pain Score (Numeric Rating Scale)
Délai: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable) |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Opioid Consumption
Délai: Postoperative 24 hours
|
Total rescue analgesic (tramadol) consumption via intravenous (IV) administration |
Postoperative 24 hours
|
|
Total Local Anesthetic Consumption
Délai: Postoperative 24 hours
|
Total bupivacaine consumed via patient-controlled analgesia (PCA) pump |
Postoperative 24 hours
|
|
Time to First Mobilization
Délai: Postoperative 24 hours
|
Time to first unassisted ambulation/movement, assessed via the Timed Up and Go (TUG) test |
Postoperative 24 hours
|
|
Length of Hospital Stay
Délai: From surgery to discharge (up to approximately 1 week)
|
Number of days from surgery to discharge |
From surgery to discharge (up to approximately 1 week)
|
|
Patient Satisfaction Score
Délai: Postoperative 24 hours
|
Satisfaction rated on a 4-point scale (1 = not satisfied, 2 = Slightly satisfied, 3 = Satisfied, 4 = very satisfied) |
Postoperative 24 hours
|
|
Systolic Blood Pressure
Délai: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Systolic blood pressure measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Diastolic Blood Pressure
Délai: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Diastolic blood pressure measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Mean Arterial Blood Pressure
Délai: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Mean arterial blood pressure (MAP) measured in mmHg |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Heart Rate
Délai: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Heart rate measured in beats per minute |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Peripheral Oxygen Saturation
Délai: Baseline and postoperative hours 1, 3, 6, 12, and 24
|
Peripheral oxygen saturation (SpO2) measured as a percentage |
Baseline and postoperative hours 1, 3, 6, 12, and 24
|
|
Block-Related Complications
Délai: Throughout study participation (up to 24 hours postoperatively)
|
Incidence of complications associated with the regional block techniques (e.g., nerve injury, infection) |
Throughout study participation (up to 24 hours postoperatively)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Furkan TONTU, MD, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
- Directeur d'études: Muzaffer GENCER, MD, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
- Directeur d'études: Murat Y Mersin, MD, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİt
Publications et liens utiles
Publications générales
- Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
- Diz Protezi Ameliyatı Sonrası Sürekli Adduktör Kanal Bloğuna Popliteal Arter ve Diz Kapsülü Arası İnfiltrasyon Bloğunun (IPACK) Eklenmesinin Etkisi DOI: 10.1080/11101849.2023.2246732
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BSH-ANES-MYM-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared beyond what is reported in publications resulting from this study.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .