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

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.

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Key information

Conditions

Fracture Pelvis Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sohag University

Sohag, 82511, Egypt

About this study

Place of the study:

Sohag University Hospitals after approval from the institutional ethical committee.

Study Design:

This prospective comparative study will be conducted on patients with fracture pelvis at the Department of Anesthesia, Intensive Care, and Pain Management,in Sohag University Hospitals after approval of the Research Ethical Committee.

Study period:

From February 2026 to August 2026.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Drug

Intraoperative and postoperative pain management

Primary outcomes

• Duration of block.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Comparison Between Dexamethasone and Dexmedetomidine as Adjuvant to Bupivacaine in Spinal Anesthesia for Cases With Fracture Pelvis Fixation Comparative Randomized Study

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 20, 2026
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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