Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.
Intrathecal Morhine or Fentanyl Compared to Intravenous Morphine in Laparoscopic Nissen Fundoplication.
Patients planned for laparoscopic Nissen fundoplication or robotic- assisted laparoscopic surgery will receive either intrathecal morphine, intrathecal fentanyl or iv morphine (control).
Perioperative total opioid consumption, Postoperative Pain Numeric Rating scale, grade of nausea and time in the postoperative ward are compared. Total grade of patient satisfaction (0-10) as well as total hospital length are also compared.
Visão geral do estudo
Status
Descrição detalhada
Study Description:
Background:
The field of laparoscopic and robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients can be suitable for laparoscopic surgery compared to open surgery, because of the less trauma and inflammatory response to the surgery and thereby faster recovery.
Extreme positioning of the patients as well as painful stimuli during and after surgery could still stress the circulatory response of the patient causing a mismatch in oxygen delivery and needs. Perioperative pain relief could be even more important during this type of surgery, when painful stimuli are more unpredictable.
This Study:
In this study painful stimuli during surgery are registered by the NOL pain monitor (Nociception Level) and intraoperative dosing of analgesia (remifentanil) is guided by the NOL index. NOL < 25 is accepted during surgery.
All patients receive preoperative: Acetaminophen 1g, Meclozinehydrocloride 25mg.
• Total opioid consumption during and after surgery is compared between three groups of patients receiving: Patients receiving Fentanyl intrathecal need 6 hours postoperative observation and patients receiving morphine intrathecal need 10 hours observation time.
- Preoperative: Oxycodone orally
- Preoperative: Intrathecal Fentanyl
- Preoperative Intrathecal Morphine. Preoperative pain assessment of the patients are Postoperative Pain from Assessment of Pain Associated with Venous Cannulation (1-10)
Anesthesia: Induction of anesthesia with propofol, remifentanil and rocuronium. During surgery: Sevoflurane + remifentanil. BIS 35-50. NOL <25. Monitoring: EKG, Blood pressure, BIS (Bispectral index) and NOL. Before wake up: Parecoxib 40mg iv. Ondansetron 4mg iv. Group 1: Morphine 0,05mg/kg iv. 10 min before waking up: 1ug/kg fentanyl to all patients. Time of surgery is also registered and volume of bleeding as well.
After surgery:
NRS (Numeric Pain Scores (0-10) are registered in the PAVU when the patient is at the PACU, when leaving the PACU as well as the maximum pain score postoperative.
Total dose of opioids converted to morphine equivalents are compared between the groups as well as the pain scores and time in the PACU.
Power calculation show a need for 63 patients to receive 80% power to show a difference in morphine-equivalents between groups of 1 mgs. (p<0,05).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Värmland County
-
Karlstad, Värmland County, Suécia, 65229
- Department of Anesthesia & Intensive Care, Central Hospital of Karlstad
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria: All patients scheduled for laparoscopic fundoplicatio surgery
-
Exclusion Criteria: -
- Age < 18 years
- Chronic pain problems or abuse.
- Pregnancy
- Exclusion ciriteria for spinal anesthesia.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Intrathecal Fentanyl 20ug
Preoperative spinal with 20ug Fentanyl
|
Intrathecal Fentanyl
|
|
Comparador Ativo: Intrathecal Morphine 100ug
Preoperative Spinal with 100ug Morhine.
|
Norhine 100ug intrathecal
Outros nomes:
|
|
Outro: Intravenous Morphine analgesia
NOL- guided Intravenous Morphine analgesia
|
NOL guided intravenous morphine analgesia
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Three different treatments of pain during during laparoscopic and/or robotic assisted laparoscopic Nissen fundoplication.
Prazo: From enrollment to the end of treatment - usually the day after surgery.
|
|
From enrollment to the end of treatment - usually the day after surgery.
|
|
Postoperative pain assessed using the Visual Analogue Scale (VAS) upon arrival to the post-anesthesia care unit (PACU), maximum VAS score in PACU, and at discharge to ward/home/patient hotel.
Prazo: From inclusion to the day after surgery.
|
Secondary outcomes:
8. Need for urinary catheterization (indwelling catheter or intermittent catheterization) within 24 hours postoperatively or at discharge. |
From inclusion to the day after surgery.
|
|
"Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0"
Prazo: "From enrollment to the end of treatment at the day after surgery
|
Paricipants arriving at the PACU with pain score according to the Visual Analogue Scale (VAS) > 3
|
"From enrollment to the end of treatment at the day after surgery
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Outros números de identificação do estudo
- 2025-04374-01
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Fentanyl Intrathecal 20ug
-
University of SurreyConcluído
-
Mylan Pharmaceuticals IncConcluído
-
Mylan Pharmaceuticals IncRescindido
-
Fundacion para la Investigacion Biomedica del Hospital...Concluído
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionConcluídoIdoso, Frágil | Deficiência, Vitamina DHolanda
-
Postgraduate Institute of Medical Education and...ConcluídoDelírio de Emergência da AnestesiaÍndia
-
CephalonConcluídoNeuropatias diabéticas | Osteoartrite | Dor lombar | EnxaquecaEstados Unidos
-
Johns Hopkins UniversityNorth American Spine SocietyConcluídoEstenose do canal lombar | Degeneração da coluna lombar | Instabilidade da coluna lombarEstados Unidos
-
University Hospital, Basel, SwitzerlandTriemli HospitalConcluído