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NCT Number: NCT07276867

Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity

The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.

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Key information

Conditions

Intrathecal Above Knee Amputation Bupivacaine Dexmedetomidine Fentanyl Lower Extremity Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma Sarcomas Spinal Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Doaa A Abdou, MD

PRINCIPAL_INVESTIGATOR

Mai M Elrawas, MD

CONTACT

[email protected]

00201222177242

Mohamed A Wadod, MD

PRINCIPAL_INVESTIGATOR

About this study

Above-knee amputation (AKA) for advanced lower limb (LL) sarcomas has a high risk of chronic pain syndromes, like phantom limb pain, and is associated with severe perioperative pain. Effective analgesia is essential for patient comfort, early rehabilitation, and improved outcomes.

Dexmedetomidine (DEX), a highly selective α2-adrenergic agonist, is a promising intrathecal (IT) adjuvant.

The combination of DEX and fentanyl may produce synergistic effects, extending block duration and improving perioperative analgesia while minimizing individual drug doses. The current approach is particularly relevant in oncologic surgeries like AKA, where optimal pain control is critical. However, supportive evidence exists in various surgical contexts.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 18 to 60 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status of II-III.
  • Height between 150-185 cm.
  • Body mass index between 18-35 kg/m².
  • Scheduled for above-knee amputation due to lower limb sarcomas.

Exclusion criteria

  • Allergy to any of the investigated drugs.
  • History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.
  • Contraindications to spinal anesthesia.
  • Pregnancy or lactation.
  • Presence of psychiatric illness or chronic pain conditions.

Treatment and study plan

Fentanyl + Dexmedetomidine

Drug

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.

Fentanyl

Drug

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.

Primary outcomes

  1. Time to first rescue analgesia

    Time frame: 24 hours postoperatively

    Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).

Secondary outcomes

  1. Total amount of morphine

    Time frame: 24 hours postoperatively

    If the Visual Analogue Scale (VAS) exceeded 3, rescue analgesia (RA) will be administered with intravenous morphine 3 mg.

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if heart rate or mean arterial blood pressure is elevated more than 20% of the baseline (after exclusion of other causes than pain).

  3. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at the Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 18, and 24 h postoperatively.

  4. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as Nausea and vomiting, shivering, bradycardia, hypotension, and respiratory depression were recorded.

Study contacts

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

Mai M Elrawas, MD

CONTACT

[email protected]

00201222177242

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity: A Randomized, Comparative Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

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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