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

January 20, 2016 updated by: Tobb University of Economics and Technology
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

80

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Female and male are being participant.

Description

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.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Tobb University of Economics and Technology

Investigators

  • Study Director: H. Evren Eker, Ass Prof, Baskent University Department of Anesthesiology

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

May 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-PMS-41

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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