- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01333943
Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia
Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle.
The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike with the FNB, the quadriceps muscle itself will still be able to function.
Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All patients ages 18-90 undergoing primary unilateral total knee arthroplasty
- Planned use of neuraxial anesthesia
- Ability to follow study protocol
- American Society of Anesthesiology (ASA) Class 1-3
Exclusion Criteria:
- Contraindication to a spinal or epidural anesthetic
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- Hypersensitivity and/or allergy to local anesthetics
- Intraoperative use of any volatile anesthetic
- Patients with a pre-existing neuropathy on the operative limb
- Contraindication to a femoral nerve block or saphenous nerve block
- Allergy to any of the study medications
- Non-English speaking patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Experimental
Saphenous (Adductor Canal) Nerve Block
|
The study group will receive the saphenous nerve block, at the level of the adductor canal.
The block will be under ultrasound guidance.
The local anesthetic will be 15 ml of 0.5% bupivicaine.
The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent.
Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Otros nombres:
|
Comparador activo: Control
Femoral Nerve Block
|
The control group will receive the femoral nerve block.
The block will be under ultrasound guidance.
The local anesthetic will be 30 ml of 0.25% bupivicaine.
The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent.
Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quadriceps Muscle Strength
Periodo de tiempo: 48 hours following administration of anesthesia.
|
Measurements were made by a handheld dynamometer while patients perform isometric exercises.
Results are presented in kilogram-force (kgF) units.
One kgF is equal to 9.80665 N.
|
48 hours following administration of anesthesia.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total Opioid Usage
Periodo de tiempo: Postoperative day 4.
|
Opioid consumption data were collected and converted to oral morphine equivalents.
|
Postoperative day 4.
|
NRS Pain Scores at Rest
Periodo de tiempo: Postoperative day 4.
|
Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
|
Postoperative day 4.
|
Patient Satisfaction With the Nerve Block.
Periodo de tiempo: 24 hours following administration of anesthesia.
|
Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
|
24 hours following administration of anesthesia.
|
Incidence of Postoperative Complications.
Periodo de tiempo: Postoperative day 4.
|
Postoperative day 4.
|
|
Total Length of Hospital Stay
Periodo de tiempo: Total length of hospital stay
|
Total length of hospital stay
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David H. Kim, MD, Hospital for Special Surgery, New York
Publicaciones y enlaces útiles
Publicaciones Generales
- Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
- Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Bohannon RW. Measuring knee extensor muscle strength. Am J Phys Med Rehabil. 2001 Jan;80(1):13-8. doi: 10.1097/00002060-200101000-00004.
- Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.
- Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
- Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
- Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305.
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2012-031
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 Artroplastia total de rodilla
-
Istanbul UniversityTerminadoArtroplastia total de rodilla | Reemplazo total de rodillaPavo
-
Singapore General HospitalTerminadoArtroplastia total de rodilla | Reemplazo total de rodillaSingapur
-
National Taiwan University HospitalDesconocidoReemplazo total de cadera | Artroplastia total de caderaTaiwán
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminadoArtroplastia total de rodilla; Artroplastia total de caderaEstados Unidos
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminadoArtroplastia total de rodilla; Artroplastia total de caderaEstados Unidos
-
Istanbul UniversityTerminadoArtroplastia total de rodilla | Reemplazo total de rodillaPavo
-
University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)TerminadoArtroplastia de Rodilla, Total | Reemplazo de rodilla, totalEstados Unidos
-
Ortho Development CorporationOregon Health and Science UniversityInscripción por invitaciónReemplazo total de cadera | Artroplastia total de caderaEstados Unidos
-
Ottawa Hospital Research InstituteThe Ottawa Hospital Academic Medical AssociationTerminadoReemplazo total de cadera | Reemplazo total de rodillaCanadá
-
Northern Orthopaedic Division, DenmarkTerminadoArtroplastia total de rodilla | Artroplastia total de caderaDinamarca
Ensayos clínicos sobre Study Group: Experimental
-
Cairo UniversityAún no reclutandoCefalea cervicogénica
-
University of MichiganTerminado
-
University of MichiganTerminado
-
Abbott NutritionTerminadoInfecciones Respiratorias en NiñosEstados Unidos
-
University of ManchesterNational Institute for Health Research, United Kingdom; Greater Manchester Mental...ReclutamientoDepresión | Desórdenes de ansiedad | Trastorno mental infantilReino Unido
-
Digisight Technologies, Inc.DesconocidoRetinopatía diabética | La degeneración macular relacionada con la edad | MetamorfopsiaEstados Unidos
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalTerminado
-
Radicle ScienceTerminadoEstrés | AnsiedadEstados Unidos
-
Arizona Oncology ServicesDesconocidoCáncer de mama localizado | Cáncer de próstata localizado | Pacientes que reciben radioterapia de haz externoEstados Unidos
-
Radicle ScienceTerminadoDepresión | Dolor | Dormir | AnsiedadEstados Unidos