Lumbar Spine Fixation
Conditions
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
Interventions
Fentanyl will be injected in the epidural space by the surgeon one or two levels above the surgical site.
DRUGepidural midazolam
midazolam will be injected in the epidural space by the surgeon one or two levels above the surgical site.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time to first call to rescue analgesia (ketorolac) | day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed