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RecruitingNCT07640516Updated Jul 13, 2026

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 .

An interventional study of Dexmedetomidine and Fentanyl (as Citrate) in Analgesia Assessment, Above Knee Amputation and Fentanyl vs Dexmedetomidine, sponsored by Kasr El Aini Hospital. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Analgesia Assessment
  • Above Knee Amputation
  • Fentanyl vs Dexmedetomidine

Keywords

  • dexmedetomidine vs fentanyl PNBs AKA
03

In context

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Neurological or intellectual disability
  • Drug abuse
  • Allergy to study drugs
  • Pregnancy
  • to regional anesthesia (e.g., coagulopathy, local infection)
  • Significant renal or hepatic impairment( plts \<75000 or >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 .
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (estimated)

Study arms

  • Active comparator
    dexmedetomidine group

    patients receiving peripheral nerve blocks for above-knee amputation with dexmedetomidine added to the local anesthetic solution

    Drug: Dexmedetomidine

  • Active comparator
    fentanyl group

    patients receiving peripheral nerve blocks for above-knee amputation with fentanyl added to the local anesthetic solution

    Drug: Fentanyl (as Citrate)

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. Time to the first request for the rescue analgesia

    the first time the patient needs analgesia postoperative

    Time frame: 24 hours postoperative

Secondary outcomes

  1. Total morphine consumption postoperative.

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

    Time frame: 24 hours postoperative

  2. Intraoperative Pain score (VAS).

    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

    Time frame: from block performance till 24 hours postopertaive

  3. Patient satisfaction

    by a scale from 1 to 5 where is 1 is very dissatisfied and 5 is very satisfied higher scores indicate greater patient satisfaction

    Time frame: 24 hours postoperative

  4. intraoperative heart rate

    measurments of intraoperative HR every 5 mins

    Time frame: intraoperative

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

    Any complication that happened intra or post operative

    Time frame: 24 hours post operative

  6. intraoperative mean arterial blood pressure

    measurment of MAP every 5 mins

    Time frame: intraoperative

07

Study locations

1 of 1 sites recruiting
  • KasrELainiH
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07640516
Responsible party
paula atef gobran kamil (professor of anesthesiology, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 10, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

paula atef gobran kamil, MBBCH, M.SC
Contact
paula.atef.gobran.1995@gmail.com
0201276604277
tamer ibrahem rouk, MD
Contact
tamer_rouk@yahoo.com
01006216826

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Dexmedetomidine · Fentanyl

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