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

Not Applicable

• Conditions: Lumbar Spine Fixation
• Interventions: Drug: Epidural fentanyl; Drug: epidural midazolam

• Registration Number: NCT06898697
• Lead Sponsor: Zagazig University

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

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-04-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the time to first call to rescue analgesia (ketorolac)	day 1

Secondary Outcome Measures

Name	Time	Method
The Numerical Pain Rating Scale	24 hours postoperative]	A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)
The total postoperative opioid consumption in the first 24 hours. opioid consumption	24 hours postoperative
the duration of hospital stay	up to 1 week	from the post operative day till discharge from hospital.

Trial Locations

Locations (1)

Faculty of Medicine,Zagazig University; 🇪🇬 Zagazig, Egypt