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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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07485127
Enrollment
60
Registered
2026-03-20
Start date
2026-02-08
Completion date
2026-08-31
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Pelvis

Brief 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.

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.

Interventions

DRUG60 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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
• Duration of block.onset of a few minutes and duration of 1.5-4 hoursSpinal 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.

Countries

Egypt

Contacts

STUDY_CHAIRWaleed A Ahmed, Lecturer

Sohag University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026