Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Femoral nerve blocks are commonly used to provide postoperative analgesia for ACL surgery. The limitation of these blocks is the incomplete analgesia they provide of the knee joint subjecting the patient to posterior knee pain. As a result, some of these patients receive rescue sciatic blocks in the postoperative care unit to cover posterior knee pain. The sciatic block provides excellent analgesia for the posterior knee; however its blockade invariably affects other territories of the sciatic nerve such as the lower leg and foot. For ACL surgery, the loss of sensation and/or motor strength to this area is unnecessary and may make ambulation more difficult. The ability to ambulate with minimal assistance may be more important for a patient undergoing an outpatient surgery when compared to an inpatient surgery.
At the posterior knee, the sciatic nerve branches off into the tibial and common peroneal nerves which give rise to sensory fibers that innervate the posterior knee. We propose targeting these terminal fibers in the popliteal fossa by infiltrating local anesthetic between the distal femoral shaft and popliteal artery thereby providing posterior knee analgesia without affecting the lower leg.This application of this block has not been studied in patients having ACL surgery. A single interim analysis is scheduled after the data for 50 cases are available.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University Feinberg School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients who are presenting for ACL reconstruction
- candidates for peripheral nerve blocks patients
- ASA 1-3
Exclusion Criteria:
- Patient refusal
- ASA Classification of 4 or higher
- Pre-existing neuropathy in the femoral or sciatic distribution
- Coagulopathy
- Infection at the site
- Non-English speaking or non-reading patients
- Chronic opioid use (>3months)
- Pregnancy
- Any other contra-indication to regional anesthesia
- Failed femoral nerve block
- Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Study Drug
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)
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30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Autres noms:
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Comparateur factice: Preservative free normal saline
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
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Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Opioid Consumption
Délai: 24 hours
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Opioid consumption (mg morphine equivalents)
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24 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Score
Délai: Pain Burden at 24hrs
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Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery.
Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain).
For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
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Pain Burden at 24hrs
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Patient Satisfaction
Délai: 24hr
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Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
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24hr
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Quality of Recovery (QoR15)
Délai: 24hrs
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Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours.
Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150).
The higher the QoR15 total score, the worse the quality of recovery reported.
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24hrs
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rohit Rahangdale, M.D., Northwestern University Feinberg School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STU00085894
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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