Pain, Postoperative
Conditions
Brief summary
Tramadol-paracetamol combination is studied in patients coming for elective spine surgery. The study drug is started at the day of surgery and continued maximum of five days. Before the surgery pain, use of pain medication, satisfaction for pain medication, adverse effects, resilience, depression and life satisfaction were asked. At the discharge and seven days after the surgery use of pain medication and adverse effects were asked. The patients were followed up to 28 days and one year after surgery.
Interventions
PROCEDUREspine surgery
Tramadol-paracetamol 325mg/37,5mg two tablets twice daily
Sponsors
University of Eastern Finland
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo tablets are used
Intervention model description
Randomised, double blinded, placebo controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age 18-75 years, * BMI 18-35 kg/m2, * informed consent obtained, * elective spine surgery
Exclusion criteria
* Age\<18 years or \>75 years * Hypersensitivity to anti-inflammatory drugs, paracetamol, tramadol or their auxiliary substances * Acute or recovered hemorrhage in gastrointestinal tract or peptic ulcer * Hemorrhagic disease * Monoamineoxidase use in past two weeks * Epilepsy * Tendency to seizure * Anti-seizure drugs in use Liver or renal failure Reduction in lung function Alcohol, drug or opioid addiction on record Acute intoxication due to alcohol, analgesics, opioids or psychopharmacon Pregnancy or breastfeeding Investigators estimation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction for pain medication | one week after surgery | satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| need for rescue pain medication | one week after surgery | Measured as amount of other pain medicines used as rescue medicine |
| Pain assessment | one week after surgery | Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain) |
| adverse effects | one week after surgery | Patient reported adverse reactions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | one year after surgery | Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain) |
Countries
Finland
Outcome results
None listed