Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, double blinded, placebo controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

placebo tablets are used

Study Groups

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tramadol/acetaminophen

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

Group Type ACTIVE_COMPARATOR

spine surgery

Intervention Type PROCEDURE

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

placebo

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

Group Type PLACEBO_COMPARATOR

spine surgery

Intervention Type PROCEDURE

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

Interventions

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spine surgery

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No