Tramadol-paracetamol Combination in Treatment of Patients... | NCT04533009

Studies
Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

NCT04533009

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Oct 26, 2023Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

spine surgery

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

May 4, 2018

First Submission Date that Met QC Criteria

Aug 26, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2023

Last Update Posted Date

Oct 26, 2023Actual

Name	Class
University of Eastern Finland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spine surgery	Procedure	Tramadol-paracetamol 325mg/37,5mg two tablets twice daily	placebo tramadol/acetaminophen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction for pain medication	satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied	one week after surgery

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merja Kokki, PhD	Kuopio University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio	Northern Savonia	70029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

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Browse Branches

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