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- Ensaio Clínico 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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-
New York
-
New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Ao controle
|
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).
|
|
Comparador Ativo: 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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-perceived Duration of Analgesia
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
NRS (Numerical Rating Scale) Pain Scores
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mary F. Chisholm, MD, Hospital for Special Surgery, New York
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Inibidores Enzimáticos
- Agentes do Sistema Sensorial
- Anestésicos
- Antiinflamatórios
- Agentes Antineoplásicos
- Antieméticos
- Agentes gastrointestinais
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Inibidores de Protease
- Anestésicos Locais
- Dexametasona
- Acetato de dexametasona
- BB 1101
- Bupivacaina
Outros números de identificação do estudo
- IRB #2012-002
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