- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01586806
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction
For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.
Depending on the randomized treatment assignment, patients may receive one of the following:
- 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
- 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
- 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.
Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
New York
-
New York, New York, États-Unis, 10021
- Hospital for Special Surgery
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.
- ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]
- BMI < 35
- Smokers included
- Ages 16-65
Exclusion Criteria:
- Patients on steroids or requiring stress dose steroids
- BMI > 35
- Patient refusal
- Allergy to study medications,
- NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks
- Lower extremity neurological dysfunction
- Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)
- Not in included age range (under 16 or over 65 years of age)
- Contraindications to the use of dexamethasone
- Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).
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 |
|---|---|
|
Comparateur placebo: Contrôler
|
This is the control treatment arm.
Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
|
Comparateur actif: Dexamethasone 1 mg
|
This is one of two treatment arms.
Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone.
Total injection volume will be 15 ml.
|
|
Comparateur actif: Dexamethasone 4 mg
|
This is one of two treatment arms.
Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone.
Total injection volume will be 15 ml.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient-perceived Duration of Analgesia
Délai: Up to 2 days following surgery
|
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
|
Up to 2 days following surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
NRS (Numerical Rating Scale) Pain Scores
Délai: Postoperative day 1
|
Patients will be asked to rate, on a scale of 0-10, their pain while at rest.
0 indicates no pain, and 10 indicates the worst pain imaginable.
|
Postoperative day 1
|
|
Patient Satisfaction
Délai: Up to 2 days following surgery
|
Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
|
Up to 2 days following surgery
|
|
Postoperative Morphine Consumption
Délai: Up to 2 days following surgery
|
Data collector will record how many opioids (i.e.
Percocet, Vicodin) the patient has used since discharge.
|
Up to 2 days following surgery
|
|
Opioid-Related Side Effects (Drowsiness)
Délai: Up to 2 days following surgery
|
Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e.
drowsiness).
The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.
|
Up to 2 days following surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mary F. Chisholm, MD, Hospital for Special Surgery, New York
Publications et liens utiles
Publications générales
- Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
- Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
- Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
- Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709. doi: 10.1213/01.ANE.0000133143.60584.38.
- Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.
- Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Reconstruction du ligament croisé antérieur
- Dexaméthasone
- Glucocorticoïdes
- Effets physiologiques des médicaments
- Utilisations thérapeutiques
- Regional Anesthesia, nerve block
- Imagerie par ultrasons
- Post-Operative Complications: muscle weakness, pain, nausea and vomiting
- Dexamethasone (as local anesthetic additive)
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents autonomes
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Agents du système sensoriel
- Anesthésiques
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Inhibiteurs de protéase
- Anesthésiques locaux
- Dexaméthasone
- Acétate de dexaméthasone
- BB 1101
- Bupivacaïne
Autres numéros d'identification d'étude
- IRB #2012-002
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