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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Active Comparator | 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. |
|
| Remifentanil | Active Comparator | remifentanil, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic thoracic pain | The percentage of patients reporting chronic thoracic pain one year after cardiac surgery. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic thoracic pain | The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CAJ Knibbe, Prof. Dr. | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital | Nieuwegein | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30211725 | Derived | de Hoogd S, Valkenburg AJ, van Dongen EPA, Daeter EJ, van Rosmalen J, Dahan A, Tibboel D, Knibbe CAJ. Short- and long-term impact of remifentanil on thermal detection and pain thresholds after cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jan;36(1):32-39. doi: 10.1097/EJA.0000000000000887. | |
| 28741894 | Derived |
| Label | URL |
|---|---|
| Study protocol | View source |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
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|
| Remifentanil | Drug | 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 | Drug | fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium. |
|
|
| 3, 6 and 12 months |
| Quality of life | The quality of life (QoL) three months, six months and one year after surgery. | 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) | 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. | 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; | 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)) | 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 | 1 year after surgery |
| Mean pain NRS (Numerical Rating Scale) | Mean NRS score during intensive care unit (ICU) stay and hospitalization. | 3-5 days during hospitalization |
| de Hoogd S, Ahlers SJGM, van Dongen EPA, van de Garde EMW, Daeter EJ, Dahan A, Tibboel D, Knibbe CAJ. Randomized Controlled Trial on the Influence of Intraoperative Remifentanil versus Fentanyl on Acute and Chronic Pain after Cardiac Surgery. Pain Pract. 2018 Apr;18(4):443-451. doi: 10.1111/papr.12615. Epub 2017 Sep 28. |
| 25429720 | Derived | de Hoogd S, Ahlers SJ, van Dongen EP, Tibboel D, Dahan A, Knibbe CA. Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial. Trials. 2014 Nov 27;15:466. doi: 10.1186/1745-6215-15-466. |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |