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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
126
fentanyl 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.
starting 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.
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
St. Antonius Hospital
Nieuwegein, Netherlands
Chronic thoracic pain
The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.
Time frame: 1 year
Chronic thoracic pain
The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery
Time frame: 3 and 6 months
Mean Numerical Rating Scale (NRS) score
The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.
Time frame: 3, 6 and 12 months
Quality of life
The quality of life (QoL) three months, six months and one year after surgery.
Time frame: 3, 6 and 12 months
Thermal detection and pain thresholds
The difference in postoperative pain thresholds three days and one year after cardiac surgery compared to the preoperative pain threshold (baseline)
Time frame: preoperative, 3 days postoperative and 1 year after surgery
Pain variability
Pain variability measured with a paradigm with electrical stimuli in only a part of the participants. The difference in pain variability preoperative, three days postoperative and one year after cardiac surgery.
Time frame: preoperative, 3 days and 1 year postoperative
Use of analgesics during and after hospitalization
The required amounts of analgesics (morphine/paracetamol) during hospital stay; The use of analgesics three months, six months and one year after cardiac surgery, measured with questionnaires;
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Time frame: 3 days during hospitalization and 3,6,12 months post surgery
Genetic variances
Genetic variances involved in pain sensitivity (e.g. GTP-cyclohydrolase 1 (GCH-1), WDFY4, Zinc Finger gene Family (ZNF), Melanocortin 1 Receptor (MC1R)) and pharmacokinetics and pharmacodynamics of opiates (e.g. glucuronosyl transferase (UGT), Multidrug Resistance-associated Protein (MRP), mu-opioid receptor gene 1 (OPRM1), Catechol-O-methyltransferase (COMT))
Time frame: Blood sample at time of surgery
Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications
Time frame: 1 year after surgery
Mean pain NRS (Numerical Rating Scale)
Mean NRS score during intensive care unit (ICU) stay and hospitalization.
Time frame: 3-5 days during hospitalization