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

March 16, 2026 updated by: Soha Mohamed, Sohag University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82511
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
onset of a few minutes and duration of 1.5-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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