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

Zagazig University

Status

Completed

Conditions

Lumbar Spine Fixation

Treatments

Drug: epidural midazolam

Drug: Epidural fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT06898697

ZU-IRB#1075/ 25-Feb-2025

Details and patient eligibility

About

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.

Full 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

Enrollment

100 patients

Sex

All

Ages

21 to 64 years old

Volunteers

No Healthy Volunteers

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.