Dexmedetomidine vs fentanyl as an add-on to bupivacaine for nerve blocks in high-risk patients undergoing above-knee amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two adjuvants—dexmedetomidine and fentanyl—used with bupivacaine in ultrasound-guided nerve blocks that serve as the sole anesthetic technique for high-risk patients undergoing unilateral above-knee amputation. The blocks target the supra-inguinal fascia iliaca and proximal sciatic nerves to provide anesthesia and analgesia while avoiding general or spinal anesthesia. Eligible participants are adults (≥18) with ASA III–IV, documented cardiac or pulmonary disease, and scheduled AKA, with several exclusion criteria to ensure safety. Outcomes likely focus on analgesic efficacy and safety of the adjuvants in this high-risk surgical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- Age ≥18 years
* Both sexes
* ASA III-IV
* Documented cardiac disease (e.g., EF \< 40%, NYHA II or higher)
* Documented pulmonary disease (e.g., COPD with FEV1 \< 60%)
* Scheduled for above-knee amputations

Exclusion Criteria:

* Neurological or intellectual disability
* Drug abuse
* Allergy to study drugs
* Pregnancy
* Contraindications to regional anesthesia (e.g., coagulopathy, local infection)
* Significant renal or hepatic impairment( plts \<75000 or INR \>1.5)
* Current anticoagulant therapy
* severe haemodynamically unstability at the time of block performance, defined as map \> 65 mmhg but achieved by high-dose vasopressors (e.g., norepinephrine ≥ 0.1 mcg/kg/min) after fluid ressuscitation .

Where it's running

• KasrELainiH
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: paula atef gobran kamil, MBBCH, M.SC
• Email: paula.atef.gobran.1995@gmail.com
• Phone: 0201276604277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.