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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fracture Pelvis
• Intervention / Treatment: Drug: 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.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: • Dexamethasone Group (n=30); Patients will receive bupivacaine plus dexamethasone.	Drug: 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
Active Comparator: • Dexmedetomidine Group (n=30); Patients will receive bupivacaine plus dexmedetomidine.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Duration of block.	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.	onset of a few minutes and duration of 1.5-4 hours

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Waleed A Ahmed, Lecturer, Sohag University

Publications and helpful links

General Publications

• Tang, P., Chen, H., Zhao, Z. and Wu, Y.(2023). Pelvic fractures. Orthopaedic Trauma Surgery: Volume 3: Axial Skeleton Fractures and Nonunion: Springer; 2023. p. 73-130.
• Meyhoff, C. S., Thomsen, C. H., Rasmussen, L. S. and Nielsen, P. R.(2006).High Incidence of Chronic Pain Following Surgery for Pelvic Fracture. Clin J Pain. ;22(2):167-72.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: Dexamethasone, Dexmedetomidine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No