Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Kuopio University Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Pain, Postoperative

Interventions

spine surgeryPROCEDURE

Tramadol-paracetamol 325mg/37,5mg two tablets twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Outcomes

Primary Outcomes

Satisfaction for pain medication

satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied

Time frame: one week after surgery

Secondary Outcomes

need for rescue pain medication

Measured as amount of other pain medicines used as rescue medicine

Time frame: one week after surgery

Pain assessment

Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)

Time frame: one week after surgery

adverse effects

Patient reported adverse reactions

Time frame: one week after surgery

Data from ClinicalTrials.gov

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