NCT02660749

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

January 18, 2016

Last Update Submit

January 20, 2016

Conditions

Heart Surgery

Outcome Measures

Primary Outcomes (1)

  • neuropathic pain assesement by DN4 score after minithoracotomy and sternotomy

    outcome measure assessed 3 months after the surgery

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female and male are being participant.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • H. Evren Eker, Ass Prof

    Baskent University Department of Anesthesiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

January 21, 2016

Record last verified: 2015-12