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Completed

NCT Number: NCT06898697

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

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.

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Key information

Conditions

Lumbar Spine Fixation

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine,Zagazig University

Zagazig, 44519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural fentanyl

Drug

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

epidural midazolam

Drug

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

Primary outcomes

  1. the time to first call to rescue analgesia (ketorolac)

    Time frame: day 1

Secondary outcomes

  1. The Numerical Pain Rating Scale

    Time frame: 24 hours postoperative]

    A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)

  2. The total postoperative opioid consumption in the first 24 hours. opioid consumption

    Time frame: 24 hours postoperative

  3. the duration of hospital stay

    Time frame: up to 1 week

    from the post operative day till discharge from hospital.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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