NCT06898697

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

Midazolam or Fentanyl as Adjuvants to Epidural Bupivacaine Plus Dexamethasone for Analgesia After Lumbar Spine Fixation: A Randomized Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

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 Fentanyl Group :.Patients will receive 10 ml of bupivacaine 0. 25 % plus 100µg fentanyl in 2ml plus 2ml (8mg) dexamethasone.In Midazolam Group: Patients will receive 10 ml of bupivacaine 0.25 % plus 2mg midazolam in 2ml plus 2 ml (8mg) dexamethasone

Conditions

• Lumbar Spine Fixation

Interventions

Type	Name	Description
DRUG	Epidural fentanyl	Fentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site.
DRUG	epidural midazolam	midazolam will be injected in the epidural space by the surgeon one or two levels above the surgical site.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-27
• Last updated: 2026-01-21

Locations

1 site across 1 country: Egypt