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Completed

NCT Number: NCT02031016

Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

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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Key information

Conditions

Chronic Pain Fentanyl Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Remifentanil Signs and Symptoms Sternotomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Antonius Hospital

Nieuwegein, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sublimaze

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.

Other names: Ultiva

Primary outcomes

  1. Chronic thoracic pain

    Time frame: 1 year

    The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

A Randomised Clinical Trial Evaluating the Effect of Remifentanil vs Fentanyl During Cardiac Surgery on the Incidence of Chronic Thoracic Pain

Acronym: REFLECT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2014
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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