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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. Juli 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

64

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Cairo, Ägypten
        • Rekrutierung
        • KasrELainiH

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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 .

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Aktiver Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to the first request for the rescue analgesia
Zeitfenster: 24 hours postoperative
the first time the patient needs analgesia postoperative
24 hours postoperative

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total morphine consumption postoperative.
Zeitfenster: 24 hours postoperative
the total dose of morphine given to the patient in the 24 hours postoperative
24 hours postoperative
Intraoperative Pain score (VAS).
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: intraoperative
measurments of intraoperative HR every 5 mins
intraoperative
Complications ( nausea - vomiting - bradycardia - hypotension .... )
Zeitfenster: 24 hours post operative
Any complication that happened intra or post operative
24 hours post operative
intraoperative mean arterial blood pressure
Zeitfenster: intraoperative
measurment of MAP every 5 mins
intraoperative

Mitarbeiter und Ermittler

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • MD-247-2025

Plan für individuelle Teilnehmerdaten (IPD)

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JA

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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