Status:

ENROLLING_BY_INVITATION

Midazolam or Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia

Lead Sponsor:

Zagazig University

Conditions:

Lumbar Spine Fixation

Eligibility:

All Genders

21-64 years

Phase:

NA

Brief Summary

The purpose of this study is to compare better postoperative analgesia after lumbar spine Fixation using either epidural bupivacaine with midazolam or fentanyl with the combination of dexamethasone.

Detailed Description

After being informed about the study and potential risks. A computer-generated randomization table will randomize all patients giving written consent into 2 groups, each containing 51 patients. In the...

Eligibility Criteria

Inclusion

  • Written informed consent from the patient.
  • Physical status: ASA 1\& II.
  • BMI = (25-30 kg/m2).
  • Type of operation: elective lumbar spine Fixation.

Exclusion

  • Altered mental state.
  • Patients with known history of allergy to study drugs.
  • Advanced hepatic, renal, cardiovascular, and respiratory diseases.
  • Patients with chronic pain.
  • Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT06898697

Start Date

April 1 2025

End Date

December 1 2025

Last Update

March 27 2025

Active Locations (1)

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Faculty of Medicine,Zagazig University

Zagazig, Egypt, 44519