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Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain (REFLECT)

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ClinicalTrials.gov Identifier: NCT02031016
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Catherijne Knibbe, St. Antonius Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Sternotomy Remifentanil Fentanyl Drug: Fentanyl Drug: Remifentanil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomised Clinical Trial Evaluating the Effect of Remifentanil vs Fentanyl During Cardiac Surgery on the Incidence of Chronic Thoracic Pain
Study Start Date : February 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fentanyl
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.
Drug: Fentanyl
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.
Other Name: Sublimaze

Drug: Fentanyl
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
Other Name: Sublimaze

Active Comparator: Remifentanil
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.
Drug: Remifentanil
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.
Other Name: Ultiva

Drug: Fentanyl
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
Other Name: Sublimaze




Primary Outcome Measures :
  1. Chronic thoracic pain [ Time Frame: 1 year ]
    The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.


Secondary Outcome Measures :
  1. Chronic thoracic pain [ Time Frame: 3 and 6 months ]
    The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery

  2. Mean Numerical Rating Scale (NRS) score [ Time Frame: 3, 6 and 12 months ]
    The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.

  3. Quality of life [ Time Frame: 3, 6 and 12 months ]
    The quality of life (QoL) three months, six months and one year after surgery.

  4. Thermal detection and pain thresholds [ Time Frame: 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)

  5. Pain variability [ Time Frame: 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.

  6. Use of analgesics during and after hospitalization [ Time Frame: 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;

  7. Genetic variances [ Time Frame: 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))

  8. 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 ]
  9. Mean pain NRS (Numerical Rating Scale) [ Time Frame: 3-5 days during hospitalization ]
    Mean NRS score during intensive care unit (ICU) stay and hospitalization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031016


Locations
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Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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Principal Investigator: CAJ Knibbe, Prof. Dr. St. Antonius Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Catherijne Knibbe, Prof. Dr., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02031016    
Other Study ID Numbers: REFLECT study
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Catherijne Knibbe, St. Antonius Hospital:
Chronic thoracic pain
Remifentanil
Fentanyl
sternotomy
Additional relevant MeSH terms:
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Chronic Pain
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics