Actively Recruiting
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
Led by National Cancer Institute, Egypt · Updated on 2025-12-11
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates whether adding intrathecal dexmedetomidine to fentanyl provides better pain relief after surgery compared to fentanyl alone. The study focuses on patients undergoing above-knee amputation for lower limb sarcomas, a surgery with a high risk of severe and chronic pain, including phantom limb pain. Effective pain control in this setting is critical for comfort and recovery. Participants will receive spinal anesthesia with hyperbaric bupivacaine combined either with fentanyl plus dexmedetomidine or fentanyl alone. One group gets 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl and 5 µg dexmedetomidine, while the other receives the same volume with only 25 µg fentanyl. This randomized, double-blind study compares these two drug combinations during surgery. During the study, researchers will monitor how long it takes before patients need additional pain medication after surgery, the total morphine used in 24 hours, fentanyl use during surgery, pain levels within 24 hours, and any adverse events. The study is sponsored by the National Cancer Institute, Egypt, and aims to improve postoperative pain management for patients undergoing this major surgery.
CONDITIONS
Brief Title
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day of surgery
Participants receive spinal anesthesia with either a combination of dexmedetomidine and fentanyl or fentanyl alone as an adjuvant to bupivacaine during above-knee amputation surgery.
1 surgical visit (in-person)
Duration - 24 hours postoperatively
Participants are monitored for pain levels, opioid consumption, and adverse events during the first 24 hours after surgery.
Postoperative monitoring visits within 24 hours
Trial Site Locations
Total: 1 location
1
National Cancer Institute
Cairo, Egypt, 11796
Actively Recruiting
Research Team
M
Mai M Elrawas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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