Steroids in posterior spinal fusio
Phase 3
Recruiting
- Conditions
- Fusion of spine, lumbar region.Fusion of spine, lumbar regionM43.26
- Registration Number
- IRCT20200502047277N6
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Age greater than 18 years
Degenerative indications for elective posterior instrumented lumbar spinal fusion surgery
Written informed consent
Exclusion Criteria
Non-degenerative pathologies (e.g., tumor, trauma, deformity, or infection)
Hypersensitivity reaction to the study drug
American Society of Anesthesiologists (ASA) physical status> 2
Concurrent psychiatric disorder
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 10-point visual analog scale (VAS) for postoperative pain. Timepoint: baseline, 2, 4, 6, 12, 24, and 48 h with 1, 4, and 12 weeks postoperatively. Method of measurement: Visual analog scale.
- Secondary Outcome Measures
Name Time Method Cumulative postoperative 24 h morphine consumption. Timepoint: 24 h postoperatively. Method of measurement: Patient-controlled analgesia device.;Oswestry disability index (ODI). Timepoint: 1 and 4 weeks postoperatively. Method of measurement: Questionnaire.;Length of stay. Timepoint: Until discharge. Method of measurement: follow-up.;Postoperative nausea and vomiting. Timepoint: Every 4 h for 24 h postoperatively. Method of measurement: follow-up and observation.;Postoperative complications. Timepoint: Once a week for 12 weeks after the surgery. Method of measurement: follow-up and observation.