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Active, not recruiting Early Phase 1

Comparison Between Dexamethasone and Dexmedetomidine in Spinal Anesthesia for Cases With Fracture Pelvis Fixation

NCT07485127 · tracked via the Priya Life Science Egypt tracker
Phase
Early Phase 1
Started
2026-02-08
Last updated
2026-03-20

Condition(s) studied

Fracture Pelvis

Investigational drug(s) / intervention(s)

60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.

60 patients will be involved, half patients will receive 13mg bupivacaine + 4 mg dexamethasone. The other half will receive 13mg bupivacaine + 4 mg dexmedetomidine. All will be monitored closely.: Intraoperative and postoperative pain management

Study summary

The aim of this study is to compare dexamethasone and dexmedetomidine as adjuvant to bupivacaine in fracture pelvis fixation as regard duration of sensory block and postoperative pain management.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age from 20 to 80 years. * Both sexes. * Patients will be classified as American Society of Anesthesiologists (ASA) class I - II. * Patient scheduled for surgical fixation of pelvic fracture. Exclusion Criteria: * Patients with drug addiction, and sepsis. * Infection at the injection site. * Sensitivity to local anesthetics. * Coagulopathy. * Kidney failure, liver failure. * History of previous paresis in the operation area.

Primary outcome measure(s)

  • • Duration of block. — onset of a few minutes and duration of 1.5-4 hours
    Spinal anesthesia involves injecting a local anesthetic into the CSF. It is preferred when the surgical site is suitable for spinal blockade, especially in patients with severe respiratory disease or difficult tracheal intubation. Bupivacaine is a long-acting local anesthetic used for spinal anesthesia. By blocking sodium channels, it produces rapid, profound sensory and motor blockade with onset within minutes and a duration of 1.5-4 hours. To enhance local anesthetic effects, various adjuvants have been studied to improve onset, duration, and block quality. Dexamethasone as an adjuvant to bupivacaine prolongs block duration, improves onset, intensity, sedation, and reduces postoperative pain. Dexmedetomidine, an alpha-2 agonist, provides sedation, anxiolysis, and analgesia; it shortens onset, prolongs block duration, delays analgesic need, and has minimal side effects.

Trial sites (1)

FacilityCityRegionStatus
Sohag University Sohag Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07485127 on ClinicalTrials.gov ↗ ← All trials in Egypt