Chronic Pain, Fentanyl, Remifentanil, Sternotomy
Conditions
Keywords
Chronic thoracic pain, Remifentanil, Fentanyl, sternotomy
Brief summary
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.
Interventions
DRUGFentanyl
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.
DRUGRemifentanil
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.
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic thoracic pain | 1 year | The percentage of patients reporting chronic thoracic pain one year after cardiac surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Numerical Rating Scale (NRS) score | 3, 6 and 12 months | The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery. |
| Quality of life | 3, 6 and 12 months | The quality of life (QoL) three months, six months and one year after surgery. |
| Thermal detection and pain thresholds | preoperative, 3 days postoperative and 1 year after surgery | The difference in postoperative pain thresholds three days and one year after cardiac surgery compared to the preoperative pain threshold (baseline) |
| Pain variability | preoperative, 3 days and 1 year postoperative | 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. |
| Chronic thoracic pain | 3 and 6 months | The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery |
| Genetic variances | Blood sample at time of surgery | 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)) |
| Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications | 1 year after surgery | — |
| Mean pain NRS (Numerical Rating Scale) | 3-5 days during hospitalization | Mean NRS score during intensive care unit (ICU) stay and hospitalization. |
| Use of analgesics during and after hospitalization | 3 days during hospitalization and 3,6,12 months post surgery | 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; |
Countries
Netherlands
Outcome results
None listed