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- Ensaio Clínico NCT02197988
TAP Versus Thoracic Epidural in Major Abdominal Resections
Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method.
This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study.
Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care.
Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- Spectrum Health
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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:
- All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures
- Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures
- Patient agrees to participate in this study and provides informed consent
Exclusion criteria:
- Surgical cases combined with thoracic surgeries
- Surgical cases where the abdominal operation is performed laparoscopically
- Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone
- Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin
- Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations)
- Adults unable to provide informed consent
- Children
- Pregnant women
- Prisoners
- Non-English speaking subjects
- Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Transversus Abdominis Plane Block
Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)
|
Transversus Abdominis Plane Block
Outros nomes:
|
|
Comparador Ativo: Thoracic Epidural Anesthesia
Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl
|
Thoracic Epidural Anesthesia
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hypotension
Prazo: First 24-72 hours postoperatively
|
The incidence of systolic blood pressure less than 90 mmHg and fluid requirements
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First 24-72 hours postoperatively
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient satisfaction relative to pain control and amount of additional narcotic usage
Prazo: Post operative day two during hospitalization
|
A short patient survey during the postoperative period which will collect information on pain management.
|
Post operative day two during hospitalization
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cost Evaluation
Prazo: Postoperative hospitalization an expected average of 6 months
|
Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.
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Postoperative hospitalization an expected average of 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mathew Chung, MD, Spectrum Health Hospitals
Publicações e links úteis
Publicações Gerais
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
- Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
- Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.
- Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.
- Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.
- Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
- Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.
- Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.
- Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.
- Conaghan P, Maxwell-Armstrong C, Bedforth N, Gornall C, Baxendale B, Hong LL, Carty HM, Acheson AG. Efficacy of transversus abdominis plane blocks in laparoscopic colorectal resections. Surg Endosc. 2010 Oct;24(10):2480-4. doi: 10.1007/s00464-010-0989-y. Epub 2010 Apr 8.
- Hilton AK, Pellegrino VA, Scheinkestel CD. Avoiding common problems associated with intravenous fluid therapy. Med J Aust. 2008 Nov 3;189(9):509-13. doi: 10.5694/j.1326-5377.2008.tb02147.x.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- Neoplasias por local
- Neoplasias
- Neoplasias Abdominais
- Efeitos Fisiológicos das Drogas
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Anestésicos Intravenosos
- Anestésicos Gerais
- Anestésicos
- Analgésicos, Opioides
- Narcóticos
- Adjuvantes, Anestesia
- Anestésicos Locais
- Fentanil
- Bupivacaina
Outros números de identificação do estudo
- 2013-218
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