- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01677143
Pre-emptive Local Anaesthesia in Gynecological Laparoscopy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study design is prospective, randomized, and double-blinded with parallel assignments. It will compare pre-emptive incisional injection of bupivacaine, 5 mg/ml, with a placebo injection (saline). The clinically relevant comparison should probably be between injection of local anaesthetics and no injection at all. However a study design like that would make blinding impossible and probably not acceptable as a research design for a study which aims to be published.
The aim of the study is to test if pre-emptive injection of long-lasting, local anaesthetics reduces post-operative pain. As local anaesthetics are already implemented in our routine, the hypothesis is that it has a positive effect by reducing postoperative pain. The null hypothesis is that there is no difference between local anaesthetics and placebo.
The recruitment of patients will be from our daily surgery, and consecutive patients who are eligible for day-case, laparoscopic surgery will be asked to participate.
To have a clinically important reduction of post-operative pain a difference of 2 units on a 0-10 numerical rating scale (NRS) is chosen for the sample size calculation. A smaller difference in pain score is not considered clinically relevant in our opinion. With a power of at least 80% this gives 20 patients in total, 10 in each arm. The power calculation was done by statistician S. Johnsen at the University of Surrey. We will include 24 patients altogether to cover for any losses to follow-up. The drop-out rates in clinical trials are usually estimated at 20 %, which would give 25 patients to be included (20/ (1-0.2) = 25). This study has, however, a very short follow-up period, so the drop-out rate is expected to be smaller. Drop-outs will be recorded and accounted for.
24 participants will be randomized in blocks of 6 patients. Block randomization is chosen to avoid pooling by chance.
All procedures will be done by one surgeon. This might be a subject for criticism as one can say that the results in the study are only true for one surgeon in a particular setting. But the need for standardization is very important in studies like this, as pointed out by Wilder-Smith (Wilder-Smith, O. H. 2000).
The time of the randomization is identified as the breakage of the study drug vial. If a potential candidate is found to satisfy any exclusion criteria or withdraws the consent before the vial is opened, the patient is not randomised. The study ID number and the study drug vial will be made available for the next potential candidate.
If a potential candidate is excluded for any reason after the breakage of the vial but before the completion of the injection of the study drug, the study ID number will be coded as Protocol Violation and excluded from the statistical analyses.
The patient, nursing staff and the surgeon will all be blinded to the substance injected.
Infiltration in the primary, umbilical site will be blind, but as close to the fascia as possible. The secondary port infiltrations will be done under visual guidance from the laparoscope, in the fascia and close to the peritoneum. Bupivacaine in a concentration of 5 mg/ml will be used and 5 ml of the solution will be injected at each port site. The patients who get placebo will get 5 ml of physiologic saline injected at each port site.
The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours. Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible. Trials measuring both movement evoked pain and pain at rest (PAR) suggests that MEP is much more intense than PAR postoperative (Srikandarajah et al, 2011). Pain will be measured on a 10 cm long Numerical Rating Scale (NRS) where 0 cm is no pain and 10 cm is severe pain. NRS is validated as a good tool for pain measurement at different ages and education levels (Gagliese et al, 2005).
Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative, and use of rescue analgesics. Pain at rest must, of course, be recorded before movement evoked pain.
The pain scoring will be done by the patient with help from the nurses at the ward at 2 and 5 hours postoperative, and both will be blinded to which arm the patient is in.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Stavanger, Noruega, 4068
- Stavanger University Hospital
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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:
- Women ≥18 years of age
- Planned day-case laparoscopic surgery
- Signed Written Informed Consent
Exclusion Criteria:
- ASA score 3-6
- Chronic pain/ Regular use of analgesics
- Inability to understand Norwegian language
- Drug or alcohol abuse
- Inability to understand or sign the Written Informed Consent form
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: bupivacaine
Injection of 5 ml bupivacaine, 5mg/ml in each port site.
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5 ml in trocar area
Outros nomes:
|
Comparador de Placebo: Placebo
Injection of 5 ml saline in each port site.
|
5 ml in trocar area
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Postoperative movement-evoked pain
Prazo: 5 hours postoperative
|
The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours.
Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible.
|
5 hours postoperative
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Pain at rest
Prazo: 2 and 5 hours postoperative
|
Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative.
|
2 and 5 hours postoperative
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Rescue analgetics
Prazo: 5 hours postoperative
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Use of rescue analgesics postoperative.
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5 hours postoperative
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Caroline Ravndal, MD, Helse Stavanger HF
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
Outros números de identificação do estudo
- SUS2012CMR01
- 2012-002356-16 (Número EudraCT)
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 .
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