Effectiveness of Perioperative Dexamethasone and Bupivacaine for Reducing Postoperative Pain in Posterior Lumbosacral Spine Surgery: A preliminary randomized double blind placebo-controlled trial
Phase 4
Completed
- Conditions
- Degenerative lumbar spine
- Registration Number
- TCTR20170807002
- Lead Sponsor
- Department of Orthopaedics Faculty of Medicine Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
1.) Age ≥ 18
2.) ASA physical status I or II
3.) Can operate patient-controlled analgesia (PCA) device
4.) Degenerative condition of spinal disease
5.) No previous spinal surgery
Exclusion Criteria
1.) Allergy to steroid or bupivacaine or morphine
2.) Prohibit to substance made from pig e.g. Muslim
3.) Pregnancy or lactating
4.) Infection, trauma or tumor spinal condition
5.) History previous spinal surgery
6.) Smoking
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison pain intensity in 48 hrs post-op by use Numeric rating scale 48 hr postoperation Pain scores (Use Numerical Rating Scale) were recorded postoperatively at 8, 16, 24 and 48 hr
- Secondary Outcome Measures
Name Time Method Comparison Morphine consumption dose(mg) in 48 hrs post-op 48hr post operation Morphine consumption dose(mg) were recorded postoperatively at 8, 16, 24 and 48 hr,Incidence of surgical site infection in 1 month post-op and pseudathrosis at 6 month post-op 1 month post-op for surgical site infection and 6 month post-op for pseudarthrosis follow up patients at out patients clinic and observe for complication