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Chronic Pain | Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

Chronic Pain research study

What is the primary objective of this study?

This study will investigate the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via sternotomy. Secondary quantitative sensory testing is performed to determine thermal and electrical detection and pain threshold and the difference in pain variability scoring. Postoperative pain scores, analgesic use, genetic variances and costs are measured.

Who is eligible to participate?

Inclusion Criteria: - Patients undergoing cardiac surgery via sternotomy (Coronary artery bypass graft (CABG) and/or valve replacement) - Patients admitted to the ICU or PACU in the St. Antonius hospital - Patients between 18 and 85 years old - Patients weighing between 45 and 140 kg - Written informed consent Exclusion Criteria: - Pregnancy/ breastfeeding - Language barrier - History of drug abuse - Neurologic condition such as peripheral neuropathy - Known remifentanil, fentanyl, morphine or paracetamol allergy - Body Mass Index (BMI) > 35 kg/m2 - Prior cardiac surgery (re-operations); - Patients with chronic pain conditions.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Pain

Sternotomy

Remifentanil

Fentanyl

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Fentanylfentanyl bolus injections on an "as needed" base, NEXT TO the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Drug:Remifentanilstarting with 0.15 ug/IBW(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Drug:Fentanylfentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fentanylfentanyl bolus injections on an "as needed" base, next to the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Remifentanilremifentanil, starting with 0.15 ug/Ideal Body Weight(IBW)(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Study Status

Completed

Start Date: February 2014

Completed Date: April 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Chronic thoracic pain

Secondary Outcome: Chronic thoracic pain

Study sponsors, principal investigator, and references

Principal Investigator: CAJ Knibbe, Prof. Dr.

Lead Sponsor: St. Antonius Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02031016

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