The Effect Of Tramadol, Metamizol and Dexketoprofen Combi... | NCT02660749

Studies
The Effect Of Tramadol, Metamizol and Dexketoprofen Combination On Chronic Pain Development After Heart Surgery

NCT02660749

Sponsor

Tobb University of Economics and Technology

Status

Unknown status

Last Update Posted

Jan 21, 2016Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Heart Surgery

Interventions

Not provided

Countries

Not provided

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

Dec 2015

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

May 2015

Primary Completion Date

May 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jan 18, 2016

First Submission Date that Met QC Criteria

Jan 20, 2016

First Posted Date

Jan 21, 2016Estimated

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

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Non Coronary Heart Surgery scheduled for the study , in patients with acute postoperative period Use of tramadol retard, metamizol and dekxketoprofen the effects on pain and character has been seen in the chronic phase targeted.

Detailed Description

This prospective study analyzed surgical thoracotomy and sternotomy patients treated with analgesic drug when higher than 4 regularly. Clinical parameters include general demographics, preoperative and postoperative clinical examination status, pain scores, neuropathic pain scores, medication side effects, additional analgesic, antiemetic and lacsatif needs, vital functions, chest drains, blood transfusion needs, duration of cardiopulmonary bypass, cross clamp time and anaesthesia time. The screening tests for neuropathic pain is the Douleur Neuropathique 4. Using at postopertative 3.month DN4 questionnaires predict persistent postoperative neuropathic pain.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neuropathic pain assesement by DN4 score after minithoracotomy and sternotomy		outcome measure assessed 3 months after the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients included between 20-70 years
ASA 1-4
Euroscore value lower than 7
Undergoned non coronary heart surgery (minithoracotomy and sternotomy)
Intensive care has been discharged from the service in 24 hours , with patients given tramadol retard , metamizol, Dexketoprofen on postoperatif first day to discharged from the hospital.

Exclusion Criteria:

Diabetes mellitus
Chronic renal failure
COPD
Uncontrolled hypertension
Epilepsy
Psychiatric disease
Malignancy
Patients with a history of cerebrovascular disease
Patients with ischemia
Patients suffering from chronic pain and analgesic use
Patients taking antidepressants and antiepileptic drug
Off-pump technique used or redo undergo cases
Ongoing postoperative time thoracic or mediastinal drains more than 48 hours remaining patients, bleeding or patients who received repeated revisions due to infection
More than 24 hours remaining in intensive care patients
Patients with long discharge duration 1 week
Patients who discontinued due to side effects of tramadol may begin after medicines.
Postoperative wound infection.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Female and male are being participant.

Sampling Method

Probability Sample