About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Age ≥18 years
Both sexes
ASA III-IV
Documented cardiac disease (e.g., EF < 40%, NYHA II or higher)
Disqualifiers
Neurological or intellectual disability
Drug abuse
Allergy to study drugs
Pregnancy
Trial design
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugDexmedetomidine added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.
Fentanyl (as Citrate)
DrugFentanyl added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.
Treatment groups
Trial outcomes
Primary outcomes
Time to the first request for the rescue analgesia
the first time the patient needs analgesia postoperative
Secondary outcomes
Total morphine consumption postoperative.
the total dose of morphine given to the patient in the 24 hours postoperative
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
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
intraoperative heart rate
measurments of intraoperative HR every 5 mins
Sponsors and contacts
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