Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Procedure: spine surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, double blinded, placebo controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tramadol/acetaminophen<br>Tramadol-paracetamol two tablets 37,5mg/325mg twice daily up to five days for patients undergoing spinal surgery | Procedure: spine surgery<br>* Tramadol-paracetamol 325mg/37,5mg two tablets twice daily<br>|
| Placebo Comparator: placebo<br>Placebo two tablets twice daily up to five days for patients undergoing spinal surgery | Procedure: spine surgery<br>* Tramadol-paracetamol 325mg/37,5mg two tablets twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction for pain medication | satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied | one week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for rescue pain medication | Measured as amount of other pain medicines used as rescue medicine | one week after surgery | 
| Pain assessment | Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain) | one week after surgery | 
| adverse effects | Patient reported adverse reactions | one week after surgery |