- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01592630
Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study
The control of postoperative pain has become a major issue in surgery awareness and it is considered an important measurement of patient satisfaction. Improvements in pain relief, including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to the surgical patient. When pain is aggressively addressed, patients respond by recovering faster.
The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting local anesthetic wound infiltration has been widely recognized as a useful adjunct to multimodal postoperative pain management. On that basis, a system that delivers a continuous local anesthetic to the surgical wound was developed, and better pain control has been achieved after several surgical procedures.
In patients undergoing abdominal procedures, such as colon resection, adequate pain control remains an issue. It is known that innervation to the antero-lateral abdomen is provided by sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been described and has shown to be effective for immediate postoperative pain control.
Recently, the use of the On-Q pain relief system with catheters placed within the TAP has been evaluated. Published results have shown significant improvement of pain control (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of prospective trials investigating the effectiveness of a continuous wound infusion with local anesthetics after general surgery procedures the investigators sought to determine the efficacy of this technique after laparoscopic colon resection procedures.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Connecticut
-
Stamford, Connecticut, Estados Unidos, 06904
- Stamford Hospital
-
Stamford, Connecticut, Estados Unidos, 06902
- Colon and Rectal Surgery
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients age 18 - 100 years of age undergoing laparoscopic colon resections.
- Patients must be able to read and write English.
Exclusion Criteria:
- Patients undergoing open procedures.
- Lap converted to open procedures.
- Patients with known liver dysfunction, or the following laboratory assays: ALT/AST/alk. Phos/total bilirubin of 2x ULN
- Cirrhosis Child's class A-C, INR >1.5. There is no specific isolated value of protein or albumin which would disqualify the subject.
- All emergent/urgent cases taken to the OR for colon resections.
- All patients with previous drug abuse/narcotic abuse history.
- Patients without the mental capacity to consent for the procedure/study.
- Subjects requiring a translator in order to sign the informed consent.
- Subjects with a history of an allergic reaction to local anesthetics or acetaminophen.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Ropivacaine
Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine
|
On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
Otros nombres:
|
Comparador de placebos: Saline
Subjects with TAP catheters attached to the On-Q pump with saline
|
On-Q pumps containing saline to be attached to TAP catheters
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to flatus
Periodo de tiempo: 1 week
|
Post-operative time measurement for the patient to pass flatus
|
1 week
|
Hospital Length of Stay
Periodo de tiempo: 1 week
|
Post-operative time measurement until patient discharge
|
1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Passage of Stool
Periodo de tiempo: 1 week
|
Post-operative time measurement for the patient to pass stool
|
1 week
|
Narcotic use
Periodo de tiempo: 1 week
|
Post-operative measurement of patient narcotic requirements
|
1 week
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Edwards CL, Fillingim RB, Keefe F. Race, ethnicity and pain. Pain. 2001 Nov;94(2):133-137. doi: 10.1016/S0304-3959(01)00408-0.
- De Oliveira GS Jr, Fitzgerald PC, Marcus RJ, Ahmad S, McCarthy RJ. A dose-ranging study of the effect of transversus abdominis block on postoperative quality of recovery and analgesia after outpatient laparoscopy. Anesth Analg. 2011 Nov;113(5):1218-25. doi: 10.1213/ANE.0b013e3182303a1a. Epub 2011 Sep 16.
- 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.
- Gupta A, Fant F, Axelsson K, Sandblom D, Rykowski J, Johansson JE, Andersson SO. Postoperative analgesia after radical retropubic prostatectomy: a double-blind comparison between low thoracic epidural and patient-controlled intravenous analgesia. Anesthesiology. 2006 Oct;105(4):784-93. doi: 10.1097/00000542-200610000-00025.
- Raue W, Haase O, Junghans T, Scharfenberg M, Muller JM, Schwenk W. 'Fast-track' multimodal rehabilitation program improves outcome after laparoscopic sigmoidectomy: a controlled prospective evaluation. Surg Endosc. 2004 Oct;18(10):1463-8. doi: 10.1007/s00464-003-9238-y. Epub 2004 Aug 26.
- Chester JF, Ravindranath K, White BD, Shanahan D, Taylor RS, Lloyd-Williams K. Wound perfusion with bupivacaine: objective evidence for efficacy in postoperative pain relief. Ann R Coll Surg Engl. 1989 Nov;71(6):394-6.
- Faucett J, Gordon N, Levine J. Differences in postoperative pain severity among four ethnic groups. J Pain Symptom Manage. 1994 Aug;9(6):383-9. doi: 10.1016/0885-3924(94)90175-9.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- 11-1017.01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre 0.2% ropivacaine
-
Nottingham University Hospitals NHS TrustUniversity of Nottingham; Sonova AGTerminadoPérdida Auditiva Sensorineural | Pérdida Auditiva, BilateralReino Unido
-
Royal Perth HospitalTerminadoEnfermedades del Sistema Nervioso Simpático CentralAustralia
-
Teva Pharmaceuticals USATerminado
-
J P LecoqTerminadoComplicaciones Postoperatorias | Dolor PostoperatorioBélgica
-
Kowa Company, Ltd.Terminado
-
University of Texas Southwestern Medical CenterUS Department of Veterans AffairsTerminadoEnsayo de aumento de dosis de nitroglicerina, 5-flourouracilo y radioterapia para el cáncer de rectoCáncer de rectoEstados Unidos
-
Assistance Publique - Hôpitaux de ParisTerminadoSarcoidosis extratorácicaFrancia
-
Kowa Company, Ltd.Terminado
-
Paul CrawfordTerminado
-
Asbjørn Mohr DrewesOdense University Hospital; Karolinska University Hospital; Hvidovre University... y otros colaboradoresActivo, no reclutandoPancreatitis AgudaDinamarca, Suecia