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

NCT ID: NCT06898697

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-12-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fentanyl

Patients will receive 10 ml of bupivacaine 0. 25 % plus 100µg fentanyl in 2ml plus 2ml (8mg) dexamethasone (14 ml total volume).

Group Type: ACTIVE_COMPARATOR

Epidural fentanyl

Intervention Type: DRUG

Fentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site.

midazolam

Patients will receive 10 ml of bupivacaine 0.25 % plus 2mg midazolam in 2ml plus 2 ml (8mg) dexamethasone with (14 ml total volume).

Group Type: ACTIVE_COMPARATOR

epidural midazolam

Intervention Type: DRUG

midazolam will be injected in the epidural space by the surgeon one or two levels above the surgical site.

Interventions

Epidural fentanyl

Fentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site.

Intervention Type: DRUG

epidural midazolam

midazolam will be injected in the epidural space by the surgeon one or two levels above the surgical site.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mohamed Medhat

assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine,Zagazig University

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

ZU-IRB#1075/ 25-Feb-2025

Identifier Type: -

Identifier Source: org_study_id