The Analgesic Efficacy of Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Ultrasound Guided Peripheral Nerve Blocks as a Solo Anesthetic Technique in High Risk Patients Undergoing Unilateral Above Knee Amputation .

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKasr El Aini Hospital

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 volunteers

Qualifiers

- 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

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Dexmedetomidine added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

  • Fentanyl (as Citrate)

    Drug

    Fentanyl added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: dexmedetomidine groupActive comparator 1 intervention
Group B: fentanyl groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to the first request for the rescue analgesia

the first time the patient needs analgesia postoperative

Time frame
24 hours postoperative

Secondary outcomes

1

Total morphine consumption postoperative.

the total dose of morphine given to the patient in the 24 hours postoperative

Time frame
24 hours postoperative
2

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

Time frame
from block performance till 24 hours postopertaive
3

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

Time frame
24 hours postoperative
4

intraoperative heart rate

measurments of intraoperative HR every 5 mins

Time frame
intraoperative

Other outcomes

Sponsors and contacts

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