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

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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Anesthesia; Dexmedetomidine; Fentanyl; Sarcomas; Bupivacaine; Lower Extremity; Above Knee Amputation; Intrathecal
• Intervention / Treatment: Drug: Fentanyl + Dexmedetomidine; Drug: Fentanyl

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai M Elrawas, MD; Phone Number: 00201222177242; Email: mai.elrawas@nci.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute
    • Contact: Mai M Elrawas, MD; Phone Number: 00201222177242; Email: mai.elrawas@nci.cu.edu.eg
    • Principal Investigator: Mohamed A Wadod, MD
    • Principal Investigator: Doaa A Abdou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group DF; Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.	Drug: Fentanyl + Dexmedetomidine; Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.
Active Comparator: Group F; Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.	Drug: Fentanyl; Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of morphine	If the Visual Analogue Scale (VAS) exceeded 3, rescue analgesia (RA) will be administered with intravenous morphine 3 mg.	24 hours postoperatively
Intraoperative fentanyl consumption	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).	Intraoperatively
Degree of pain	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.	24 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as Nausea and vomiting, shivering, bradycardia, hypotension, and respiratory depression were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Piperidines; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: AP2509-501-125-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No