Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).
The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.
Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.
The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General 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:
- Scheduled cesarean delivery via Pfannenstiel incision;
- Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.
Exclusion Criteria:
- Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
- Contraindication to neuraxial anesthetic;
- Allergy to local anesthetic;
- Planned general anesthetic.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo
Normal saline will be infiltrated
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placebo injection in the Pfannenstiel incision
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|
Comparador Ativo: Intervention
Liposomal bupivacaine will be infiltrated
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liposomal bupivacaine injection in the Pfannenstiel incision
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Score With Activity
Prazo: at 48-hours post-operatively
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Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39 |
at 48-hours post-operatively
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Score With Activity
Prazo: at 72 -hours post-operatively
|
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment |
at 72 -hours post-operatively
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Total Opioid Use (in Morphine Equivalents)
Prazo: 72-hours post-operatively
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Total opioid use (in morphine equivalents)
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72-hours post-operatively
|
|
Satisfaction With Post-operative Pain Control
Prazo: 48-hours post-operatively
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PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied
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48-hours post-operatively
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Postoperative Hospital Length of Stay
Prazo: 0 to 96 hours postoperatively
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Postoperative hospital length of stay
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0 to 96 hours postoperatively
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Number of Patients With Wound Complication - Separation, Dehiscence, Infection
Prazo: 14 days postoperatively
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Wound complication - separation, dehiscence, infection
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14 days postoperatively
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Number of Patients With Allergic Reaction Attributable to Local Anesthestic
Prazo: 0-96 hours postoperatively
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incisional rash, hives, anaphylaxis
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0-96 hours postoperatively
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Operative Time of Cesarean Delivery
Prazo: Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
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Operative time of cesarean delivery
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Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
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Patient Satisfaction With Pain Management at 6w Postpartum
Prazo: 6 weeks postpartum
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Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used
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6 weeks postpartum
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William H Barth, Jr, MD, Massachusetts General Hospital
Publicações e links úteis
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016P002307/MGH
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