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

Heart Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02660749
• Other study ID #: 2015-PMS-41
• Status: Active, not recruiting
• Phase: N/A
• First received: January 18, 2016
• Last updated: January 20, 2016
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Tobb University of Economics and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Turkey: Ministry of Health of Pharmaceutical and Medical Device Organization:Turkey
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Heart Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tobb University of Economics and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropathic pain assesement by DN4 score after minithoracotomy and sternotomy		outcome measure assessed 3 months after the surgery	Yes