search
Back to results

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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
spine surgery
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

tramadol/acetaminophen

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Satisfaction for pain medication
satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied

Secondary Outcome Measures

need for rescue pain medication
Measured as amount of other pain medicines used as rescue medicine
Pain assessment
Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
adverse effects
Patient reported adverse reactions

Full Information

First Posted
May 4, 2018
Last Updated
August 26, 2020
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
search

1. Study Identification

Unique Protocol Identification Number
NCT04533009
Brief Title
Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery
Acronym
TRAMAPARAS
Official Title
Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomised, double blinded, placebo controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
placebo tablets are used
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tramadol/acetaminophen
Arm Type
Active Comparator
Arm Description
Tramadol-paracetamol two tablets 37,5mg/325mg twice daily up to five days for patients undergoing spinal surgery
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo two tablets twice daily up to five days for patients undergoing spinal surgery
Intervention Type
Procedure
Intervention Name(s)
spine surgery
Intervention Description
Tramadol-paracetamol 325mg/37,5mg two tablets twice daily
Primary Outcome Measure Information:
Title
Satisfaction for pain medication
Description
satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied
Time Frame
one week after surgery
Secondary Outcome Measure Information:
Title
need for rescue pain medication
Description
Measured as amount of other pain medicines used as rescue medicine
Time Frame
one week after surgery
Title
Pain assessment
Description
Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
Time Frame
one week after surgery
Title
adverse effects
Description
Patient reported adverse reactions
Time Frame
one week after surgery
Other Pre-specified Outcome Measures:
Title
Pain assessment
Description
Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
Time Frame
one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merja Kokki, PhD
Phone
+358447174764
Email
merja.kokki@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, PhD
Phone
+358447174764

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

We'll reach out to this number within 24 hrs