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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07617064
WALANT Versus Local Anesthesia With Tourniquet for Carpal Tunnel Decompression (WALANT vs LA-T)
Intraoperative Pain During Carpal Tunnel Release: Wide-Awake Local Anesthesia No Tourniquet Versus Local Anesthesia and Tourniquet - A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Al-Azhar University Hospital (Neurosurgery Department)
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Giza, Egipto
- Misr University for Science and Technology Hospital (Orthopedic Surgery Department)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults (≥18 years) with clinically and electrophysiologically confirmed carpal tunnel syndrome.
Candidate for surgical treatment with open carpal tunnel decompression.
American Society of Anesthesiologists (ASA) physical status I or II.
Able and willing to provide written informed consent.
Exclusion Criteria:
- Surgery-related anxiety requiring sedation or general anesthesia.
Known contraindication or allergy to lidocaine or epinephrine.
Active local or systemic infection at or near the surgical site.
ASA physical status III or higher.
Pregnancy or breastfeeding.
Any condition preventing reliable pain scoring or follow-up according to investigator judgment.
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 |
|---|---|
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Experimental: WALANT (Wide-Awake Local Anesthesia No Tourniquet)
"Patients received wide-awake local anesthesia with epinephrine infiltration in the operative field, without arm tourniquet or routine sedation, for open carpal tunnel decompression."
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"Twenty milliliters of 1% lidocaine (200 mg) with epinephrine 1:100,000, buffered with 8.4% sodium bicarbonate at a 10:1 ratio, were infiltrated into the operative field approximately 20 minutes before incision.
No tourniquet was applied.
A mini-open CTD through a 2-3 cm incision was performed in a minor procedure room under full aseptic technique.
Hemostasis relied on epinephrine-mediated vasoconstriction and meticulous surgery."
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Comparador activo: Local Anesthesia With Tourniquet (LA-T)
"Patients received buffered lidocaine without epinephrine and an upper-arm pneumatic tourniquet for open carpal tunnel decompression."
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"Twenty milliliters of 1% lidocaine (200 mg) buffered identically to the WALANT solution but without epinephrine were infiltrated approximately 5 minutes before incision in the operating room.
A blood pressure cuff tourniquet was placed above the elbow, inflated to 100 mmHg above systolic pressure after arm elevation and draping, and released after wound closure.
Mini-open CTD was performed through a 2-3 cm incision under standard aseptic conditions."
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative Pain (VAS)
Periodo de tiempo: Intraoperative.
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"Overall intraoperative pain scored by the patient using a visual analog scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
The patient rated the overall pain experienced during surgery on a standardized questionnaire administered by a blinded assessor."
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Intraoperative.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Infiltration Pain (VAS)
Periodo de tiempo: Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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"Pain at the time of local anesthetic infiltration, scored on a VAS 0-10."
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Perioperative " During local anesthetic injection, assessed immediately after infiltration."
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Tourniquet Pain (VAS) - LA-T Group Only
Periodo de tiempo: Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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"Tourniquet-specific pain in the LA-T group, scored on VAS 0-10, recorded separately from overall intraoperative pain."
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Perioperative " During tourniquet inflation, assessed after the primary intraoperative pain rating."
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Operative Time
Periodo de tiempo: Intraoperative (from first skin incision to final skin closure).
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"Operative time in minutes, recorded from incision to completion of skin closure."
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Intraoperative (from first skin incision to final skin closure).
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Patient Satisfaction With Operating Room Experience
Periodo de tiempo: Day 1 Postoperative
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"Global patient satisfaction with the operating room experience, assessed using a numeric rating scale from 0 (not satisfied) to 10 (fully satisfied)."
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Day 1 Postoperative
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Intraoperative Complications
Periodo de tiempo: Baseline up to 30 days postoperatively.
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"Any deviation from the normal operative course, including bleeding requiring intervention, nerve injury, or other intraoperative adverse events, captured on the standardized operative record and postoperative questionnaire."
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Baseline up to 30 days postoperatively.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohammed S.K. Hamza, MD, PhD, Faculty of Medicine, Misr University for Science and Technology, Giza, Egypt
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 (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuropatía mediana
- Mononeuropatías
- Síndromes de compresión nerviosa
- Trastornos Traumáticos Acumulativos
- Torceduras y esguinces
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Síndrome del túnel carpiano
- Satisfacción del paciente
- Equipos y suministros
- Anestesia y analgesia
- Anestesia, conducción
- Anestesia
- Anestesia, local
- Torniquetes
Otros números de identificación del estudio
- WALANTvsLAT-CTD-RCT-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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