Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery (TRAMAPARAS)

Kuopio University Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Pain, Postoperative

Treatments: Procedure: spine surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04533009

2017-11-10

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

tramadol/acetaminophen

Active Comparator group

Description:

Tramadol-paracetamol two tablets 37,5mg/325mg twice daily up to five days for patients undergoing spinal surgery

Treatment:

Procedure: spine surgery

placebo

Placebo Comparator group

Description:

Placebo two tablets twice daily up to five days for patients undergoing spinal surgery

Treatment:

Procedure: spine surgery