Above Knee Amputation, Bupivacaine, Dexmedetomidine, Fentanyl, Intrathecal, Lower Extremity, Sarcomas, Spinal Anesthesia
Conditions
Brief summary
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
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.
Interventions
DRUGFentanyl + Dexmedetomidine
Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.
DRUGFentanyl
Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue analgesia | 24 hours postoperatively | Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of morphine | 24 hours postoperatively | If the Visual Analogue Scale (VAS) exceeded 3, rescue analgesia (RA) will be administered with intravenous morphine 3 mg. |
| Intraoperative fentanyl consumption | 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). |
| Degree of pain | 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. |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as Nausea and vomiting, shivering, bradycardia, hypotension, and respiratory depression were recorded. |
Countries
Egypt
Contacts
Primary ContactMai M Elrawas, MD
Outcome results
None listed