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The Analgesic Efficacy of Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Ultrasound Guided Peripheral Nerve Blocks as a Solo Anesthetic Technique in High Risk Patients Undergoing Unilateral Above Knee Amputation .

10 de julio de 2026 actualizado por: paula atef gobran kamil, Kasr El Aini Hospital

The Analgesic Efficacy of Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Ultrasound Guided Peripheral Nerve Blocks as a Solo Anesthetic Technique in High Risk Patients Undergoing Unilateral Above Knee Amputation : A Randomized Double Blinded Study

The aim of this study is to compare the analgesic efficacy and safety of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided combined supra-inguinal fascia iliaca and proximal sciatic nerve blocks used as a solo anesthetic technique in high-risk patients undergoing unilateral above knee amputation.

Descripción general del estudio

Descripción detallada

Above knee amputation (AKA) is a major surgical procedure often performed for non salvageable lower limb such as severe trauma , peripheral arterial diseases or infection . however it carries significant risks and complications . The overall mortality and morbidity rates are also substantial, with one-year mortality rates reported as high as 40-50% in some populations.

Anesthesia in above-knee amputation procedures poses its own set of risks, especially in patients with advanced age or multiple comorbidities. General anesthesia (GA) may be associated with postoperative pulmonary complications, prolonged recovery, and hemodynamic instability. On the other hand, spinal anesthesia offers benefits such as reduced thromboembolic events and faster postoperative recovery, but carries risks including hypotension, spinal hematoma, and post-dural puncture headache .

Peripheral nerve blocks (PNBs) as a solo anesthetic technique offer significant hemodynamic advantages compared to neuroaxial and general anesthesia , this makes them especially beneficial for patients with cardiovascular compromise or bad chest conditions.

Effective pain management is crucial to improve patient outcomes, promoting early mobilization, and reducing the risks of complications such as deep vein thrombosis or chronic pain syndromes .

Patients with multiple risk factors such as cardiovascular disease, respiratory problems have a higher risk of complications when general or spinal anesthesia is used. In such cases ultrasound guided regional anesthesia becomes an excellent alternative .. So The combination of supra-inguinal fascia iliaca block and sciatic nerve block has emerged as a promising regional anesthetic approach for above-knee amputation, particularly in patients who are poor candidates for general or neuraxial anesthesia. This technique provides comprehensive coverage of the femoral, lateral femoral cutaneous, obturator, and sciatic nerves, allowing for adequate surgical anesthesia without the need for airway manipulation. It offers advantages such as hemodynamic stability, reduced opioid consumption, and fewer respiratory complications, making it especially beneficial in elderly and high-risk patients. When performed under ultrasound guidance, this approach enhances block accuracy and safety, positioning it as a viable solo anesthetic technique for AKA. The technique allows for adequate surgical anesthesia with preserved hemodynamic stability and minimal systemic drug exposure. Clinical reports have demonstrated its success in providing effective anesthesia with high patient and surgeon satisfaction, especially when performed under ultrasound guidance.

Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties which could improve the quality of the block while reducing opioid consumption and their associated side effects. It reduces pain after knee arthroscopy mainly by peripheral and central mechanisms through stimulation of presynaptic α2- adrenoceptors .

On the other hand, fentanyl, an opioid, is commonly used to provide potent analgesia in regional blocks but carries risks of respiratory depression and other opioid-related complications . There over, this study aims to compare dexmedetomidine versus fentanyl as adjuvant to bupivacaine in ultrasound-guided supra inguinal fascia iliaca and sciatic nerve block for anesthetic management for unilateral above knee amputation in high risk patients as a solo anesthetic technique ..

While several studies have evaluated the efficacy of peripheral nerve blocks in lower limb surgeries, few have investigated their use as a sole anesthetic technique specifically in high-risk patients undergoing above-knee amputation (AKA). Moreover, the comparative role of different adjuvants such as dexmedetomidine versus fentanyl in this setting remains underexplored. There is a clear need for well-designed randomized trials to guide anesthetic decision-making in this fragile patient population.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

64

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: tamer ibrahem rouk, MD
  • Número de teléfono: 01006216826
  • Correo electrónico: tamer_rouk@yahoo.com

Ubicaciones de estudio

      • Cairo, Egipto
        • Reclutamiento
        • KasrELainiH

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • - Age ≥18 years
  • Both sexes
  • ASA III-IV
  • Documented cardiac disease (e.g., EF < 40%, NYHA II or higher)
  • Documented pulmonary disease (e.g., COPD with FEV1 < 60%)
  • Scheduled for above-knee amputations

Exclusion Criteria:

  • Neurological or intellectual disability
  • Drug abuse
  • Allergy to study drugs
  • Pregnancy
  • Contraindications to regional anesthesia (e.g., coagulopathy, local infection)
  • Significant renal or hepatic impairment( plts <75000 or INR >1.5)
  • Current anticoagulant therapy
  • severe haemodynamically unstability at the time of block performance, defined as map > 65 mmhg but achieved by high-dose vasopressors (e.g., norepinephrine ≥ 0.1 mcg/kg/min) after fluid ressuscitation .

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: dexmedetomidine group
patients receiving peripheral nerve blocks for above-knee amputation with dexmedetomidine added to the local anesthetic solution
Dexmedetomidine added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.
Comparador activo: fentanyl group
patients receiving peripheral nerve blocks for above-knee amputation with fentanyl added to the local anesthetic solution
Fentanyl added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to the first request for the rescue analgesia
Periodo de tiempo: 24 hours postoperative
the first time the patient needs analgesia postoperative
24 hours postoperative

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total morphine consumption postoperative.
Periodo de tiempo: 24 hours postoperative
the total dose of morphine given to the patient in the 24 hours postoperative
24 hours postoperative
Intraoperative Pain score (VAS).
Periodo de tiempo: from block performance till 24 hours postopertaive
assessment of pain intensity using the visual analogue score (VAS) ranging from 0 to 10 where 0 indicates no pain and 10 indicate the worst pain imaginable , higher scores indicate worse pain
from block performance till 24 hours postopertaive
Patient satisfaction
Periodo de tiempo: 24 hours postoperative
by a scale from 1 to 5 where is 1 is very dissatisfied and 5 is very satisfied higher scores indicate greater patient satisfaction
24 hours postoperative
intraoperative heart rate
Periodo de tiempo: intraoperative
measurments of intraoperative HR every 5 mins
intraoperative
Complications ( nausea - vomiting - bradycardia - hypotension .... )
Periodo de tiempo: 24 hours post operative
Any complication that happened intra or post operative
24 hours post operative
intraoperative mean arterial blood pressure
Periodo de tiempo: intraoperative
measurment of MAP every 5 mins
intraoperative

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de julio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MD-247-2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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. .

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