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

Early Phase 1Active Not RecruitingNCT07485127

Sohag University60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fracture Pelvis

Interventions

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sohag University

Sohag, Egypt

Outcomes

Primary Outcomes

• 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.

Time frame: onset of a few minutes and duration of 1.5-4 hours

Data from ClinicalTrials.gov

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