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

October 25, 2023 updated by: Kuopio University Hospital
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: one year after surgery
Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

University of Eastern Finland

Investigators

  • Principal Investigator: Merja Kokki, PhD, Kuopio University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-11-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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