Pain, Postoperative
Conditions
Brief summary
To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.
Interventions
DRUGDexmedetomidine
DRUGOxycodone
Sponsors
University of Helsinki
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia. * Written informed consent from the participating subject
Exclusion criteria
* A previous history of intolerance to the study drug or related compounds and additives * Concomitant drug therapy with oxycodone or buprenorphine. * History of ischemic heart disease or conduction disturbance * BMI \> 35 * Existing significant haematological, endocrine, metabolic or gastrointestinal disease * History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent * Allergy to dexmedetomidine or oxycodone * Blood loss exceeding 1500 ml during operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid consumption (mg) postoperatively | 24 hours | Change from baseline opioid consumption (mg) postoperatively at 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in numerical rating scale (NRS 0-10) | 72 hours | Number of patients with numerical rating scale value under 3 |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 72 hours | Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery |
Countries
Finland
Outcome results
None listed