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NCT Number: NCT07640516

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 .

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KasrELainiH

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

Fentanyl (as Citrate)

Drug

Fentanyl added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

Primary outcomes

  1. Time to the first request for the rescue analgesia

    Time frame: 24 hours postoperative

    the first time the patient needs analgesia postoperative

Secondary outcomes

  1. Total morphine consumption postoperative.

    Time frame: 24 hours postoperative

    the total dose of morphine given to the patient in the 24 hours postoperative

  2. Intraoperative Pain score (VAS).

    Time frame: 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

  3. Patient satisfaction

    Time frame: 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

  4. intraoperative heart rate

    Time frame: intraoperative

    measurments of intraoperative HR every 5 mins

  5. Complications ( nausea - vomiting - bradycardia - hypotension .... )

    Time frame: 24 hours post operative

    Any complication that happened intra or post operative

  6. intraoperative mean arterial blood pressure

    Time frame: intraoperative

    measurment of MAP every 5 mins

Study contacts

Contact information is provided by the study sponsor or research team.

paula atef gobran kamil, MBBCH, M.SC

CONTACT

[email protected]

0201276604277

tamer ibrahem rouk, MD

CONTACT

[email protected]

01006216826

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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