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Conditions
Interventions
Intervention 1: Intervention group: dexamethasone (4 mg) + ropivacaine (0.2%, 25 ml) + epinephrine (1:200000) using Hemo-vac drain with epidural drug delivery capability. The epidural injection is rep
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: written consent to participate in the study age 18 to 65 candidate for instrumentation in posterior lumbar spine surgeries ASA class I-II
Exclusion criteria
Exclusion criteria: patients withholding consent infection tumor fracture in the area of surgery speech impairments mental retardation preoperative neurological disorders allergy to anesthetic drugs patients with pacemaker patients that have used ropivacaine, opioids, and NSAIDs one week before the surgery failure in epidural catheter placement during the surgery pregnancy nausea and vomiting severe hemodynamic changes such as bradycardia or blood pressure drop higher than 30% of average blood pressure seizure severe headache progressive paresthesia of the lower limbs decreased level of consciousness changes in respiratory rate and order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of pain at the state of rest. Timepoint: Before the surgery, 8, 16, 24, 32, 40, 48 hours, and 4 months after the surgery. Method of measurement: Asking the patient, based on visual analogue scale (0=no pain, 1-3=mild pain, 4-7=moderate pain, and 8-10=severe pain).;The level of pain at the state of motion. Timepoint: Before the surgery, 8, 16, 24, 32, 40, 48 hours, and 4 months after the surgery. Method of measurement: Asking the patient, based on visual analogue scale (0=no pain, 1-3=mild pain, 4-7=moderate pain, and 8-10=severe pain).;The level of patient satisfaction with pain management. Timepoint: Upon discharge from the hospital, and 4 months after the surgery. Method of measurement: Asking the patient, based on a 0 to 10 score (0=not satisfied, 1-3=relative satisfaction, 4-7=high level of satisfaction, and 8-10=completely satisfied).;The level of surgeon satisfaction (i.e., operating environment and the rate of bleeding). Timepoint: At the end of the surgery. Method of measurement: Asking the surgeon, based on a 0 to 10 score (0-2=not satisfied, 3-5=low level of satisfaction, 6-8=relative satisfaction, and 9-10=completely satisfied).;The time of starting to move. Timepoint: The time of starting to move. Method of measurement: Asking the nurse.;The time to first analgesic request. Timepoint: The time to first analgesic request. Method of measurement: Asking the nurse.;The amount of postoperative bleeding. Timepoint: 48 hours after the surgery. Method of measurement: Evaluation of blood volume in Hemovac drain during the first 48 hours after surgery minus the volume of drug solution injected into the surgical wound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Rezaee
Karaj University of Medical Sciences
Outcome results
None listed