Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
Normal saline will be infiltrated
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placebo injection in the Pfannenstiel incision
|
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Comparador activo: Intervention
Liposomal bupivacaine will be infiltrated
|
liposomal bupivacaine injection in the Pfannenstiel incision
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Score With Activity
Periodo de tiempo: at 48-hours post-operatively
|
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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Score With Activity
Periodo de tiempo: 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
|
|
Total Opioid Use (in Morphine Equivalents)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Postoperative Hospital Length of Stay
Periodo de tiempo: 0 to 96 hours postoperatively
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Postoperative hospital length of stay
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0 to 96 hours postoperatively
|
|
Number of Patients With Wound Complication - Separation, Dehiscence, Infection
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 weeks postpartum
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Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used
|
6 weeks postpartum
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William H Barth, Jr, MD, Massachusetts General Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016P002307/MGH
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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