Dexmedetomidine versus fentanyl added to heavy bupivacaine for spinal anesthesia in lower limb orthopedic surgery

Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.

This trial will test whether adding a small dose of dexmedetomidine or fentanyl to heavy bupivacaine makes spinal anesthesia work longer and keeps blood pressure steadier for adults having elective lower limb orthopedic surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: Port Said University hospital (Academic / other)
• Locations: 1 site (Port Said)
• Trial ID: NCT07078201 on ClinicalTrials.gov

What this trial studies

This randomized, controlled Phase 4 trial enrolled 40 adults (ASA I–II) aged 20–60 undergoing elective lower limb orthopedic procedures at Port Said University. Participants received intrathecal 0.5% heavy bupivacaine with either 4 µg dexmedetomidine or a fentanyl adjuvant and were followed perioperatively. Key outcomes included onset and duration of motor block, duration of analgesia, and intraoperative hemodynamic stability including hypotension and bradycardia. Side effects such as nausea, pruritus, urinary retention, and respiratory depression were also monitored during immediate postoperative follow-up.

Who should consider this trial

Good fit: Adults 20–60 years old with ASA physical status I–II scheduled for elective lower limb orthopedic surgery who meet the study height (150–180 cm) and weight (50–70 kg) criteria and have no contraindications to spinal anesthesia.

Not a fit: Patients with ASA ≥3, cardiac conduction disorders or dysrhythmia, pregnancy, local infection at the injection site, neurological disease, or those outside the specified age/height/weight ranges are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the better adjuvant could prolong spinal anesthesia, reduce the need for additional pain medications, and improve intraoperative blood pressure and heart rate stability.

How similar studies have performed: Previous randomized trials and meta-analyses generally show intrathecal dexmedetomidine can prolong sensory and motor block and analgesia compared with opioids or placebo, though it may increase risks of bradycardia or hypotension.

Eligibility criteria

Inclusion Criteria:

1. The patient aged range from 20 to 60 years
2. ASA 1 and 2
3. Patient prepared for elective lower limb orthopaedic surgeries.
4. Height 150-180 cm.
5. Weight 50-70 kg. 6- Either sex male or female.

Exclusion Criteria:

\- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection.

4- Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.

Where this trial is running

Port Said

• Port said university — Port Said, Egypt (Recruiting)

Study contacts

• Study coordinator: Nashwa gomaa Ahmed, MD

Conditions Spinal Anesthesia Duration