Two commonly used anesthesia during cardiac surgery (remifentanil and fentanyl) will be compared; the effect of these anesthesia on the development of chronic thoracic pain will be measured.

A randomised clinical trial evaluating the effect of remifentanil vs fentanyl during cardiac surgery on the incidence of chronic thoracic pain. - REFLECT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000201-23-NL

Enrollment

126

Registered

2013-05-30

Start date

2013-08-30

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic thoracic pain after cardiac surgery via sternotomy

Interventions

Trade Name: Remifentanil HCL 2 mg vial Product Name: Remifentanil HCL Pharmaceutical Form: Powder for solution for injection/infusion Trade Name: Fentanyl 100 ug = 2 ml vial Product Name: Fentanyl P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients living in Utrecht and surroundings undergoing cardiac surgery via sternotomy, including a CABG and/or valve replacement, admitted to the ICU or PACU in the St. Antonius hospital, between 18 and 85 years old, weighing between 45 and 140 kg, written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63

Exclusion criteria

Exclusion criteria: - Pregnancy/ breastfeeding - Language barrier - History of drug abuse - Neurologic condition such as peripheral neuropathy - Known morphine or paracetamol allergy - BMI > 35 kg/m2

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic pain one year after cardiac surgery.;Secondary Objective: -percentage of patients with chronic thoracic pain and their mean NRS scores three months and six months after cardiac surgery. - effect on the quality of life (QoL) and on the use of analgesics three months, six months and one year after surgery - pain thresholds will be measured, evaluating the difference in postoperative pain threshold (three days and one year after surgery) compared to preoperative pain threshold (baseline), using quantitative sensory testing. - other aspects in the postoperative period, e.g. NRS scores, postoperative consumption of analgesics, length of ICU- and hospital stay, safety parameters of remifentanil - influence of genetic variances involved in pain sensitivity (e.g. GCH-1, WDF-4, ZNF, MC1R) and in pharmacokinetics and pharmacodynamics of opiates (e.g. UGT, MRP, OPRM1, COMT) will be investigated. - cost-effectiveness analysis alongside the RCT with a 12 month follow-up will be performed. ;Primary end point(s): The percentage of patients reporting chronic thoracic pain one year after cardiac surgery. ;Timepoint(s) of evaluation of this end point: one year after cardiac surgery	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic pain one year after cardiac surgery.;Secondary Objective: -percentage of patients with chronic thoracic pain and their mean NRS scores three months and six months after cardiac surgery. - effect on the quality of life (QoL) and on the use of analgesics three months, six months and one year after surgery - pain thresholds will be measured, evaluating the difference in postoperative pain threshold (three days and one year after surgery) compared to preoperative pain threshold (baseline), using quantitative sensory testing. - other aspects in the postoperative period, e.g. NRS scores, postoperative consumption of analgesics, length of ICU- and hospital stay, safety parameters of remifentanil - influence of genetic variances involved in pain sensitivity (e.g. GCH-1, WDF-4, ZNF, MC1R) and in pharmacokinetics and pharmacodynamics of opiates (e.g. UGT, MRP, OPRM1, COMT) will be investigated. - cost-effectiveness analysis alongside the RCT with a 12 month follow-up will be performed. ;Primary end point(s): The percentage of patients reporting chronic thoracic pain one year after cardiac surgery. ;Timepoint(s) of evaluation of this end point: one year after cardiac surgery

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Secondary

Measure	Time frame
Secondary end point(s): - The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery - The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery. - The quality of life (QoL) three months, six months and one year after surgery. - The difference in postoperative pain thresholds three days and one year after cardiac surgery compared to the preoperative pain threshold (baseline) - The use of analgesics three months, six months and one year after cardiac surgery. - The percentage of patients with at least one NRS-score of = 4 at rest during ICU and hospital stay - The mean NRS per patient at rest during ICU stay - The required amounts of analgesics (morphine/paracetamol) during hospital stay - Length of ICU and hospital stay - Total administered amount of remifentanil and fentanyl - Total medical costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications - Productivity costs during one year (i.e., foregone paid and unpaid work and reduced productivity while at work) - Cost-effectiveness, expressed as incremental costs per case of chronic pain at 12 months after cardiac surgery avoided and incremental costs per quality-adjusted life-year (QALY) gained - Safety parameters of remifentanil; such as nausea, constipation, respiratory depression, duration of ventilation, hallucinations, delirium, Glascow Coma Scale, renal function) - Genetic variances involved in pain sensitivity (e.g. GCH-1, WDF-4, ZNF, MC1R) and pharmacokinetics and pharmacodynamics of opiates (e.g. UGT, MRP, OPRM1, COMT) ;Timepoint(s) of evaluation of this end point: peri- and postoperative period, 3 months, 6 months and 1 year after cardiac surgery	—

Measure

Time frame

Secondary end point(s): - The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery - The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery. - The quality of life (QoL) three months, six months and one year after surgery. - The difference in postoperative pain thresholds three days and one year after cardiac surgery compared to the preoperative pain threshold (baseline) - The use of analgesics three months, six months and one year after cardiac surgery. - The percentage of patients with at least one NRS-score of = 4 at rest during ICU and hospital stay - The mean NRS per patient at rest during ICU stay - The required amounts of analgesics (morphine/paracetamol) during hospital stay - Length of ICU and hospital stay - Total administered amount of remifentanil and fentanyl - Total medical costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications - Productivity costs during one year (i.e., foregone paid and unpaid work and reduced productivity while at work) - Cost-effectiveness, expressed as incremental costs per case of chronic pain at 12 months after cardiac surgery avoided and incremental costs per quality-adjusted life-year (QALY) gained - Safety parameters of remifentanil; such as nausea, constipation, respiratory depression, duration of ventilation, hallucinations, delirium, Glascow Coma Scale, renal function) - Genetic variances involved in pain sensitivity (e.g. GCH-1, WDF-4, ZNF, MC1R) and pharmacokinetics and pharmacodynamics of opiates (e.g. UGT, MRP, OPRM1, COMT) ;Timepoint(s) of evaluation of this end point: peri- and postoperative period, 3 months, 6 months and 1 year after cardiac surgery

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Countries

Netherlands

Contacts

Public ContactClinical Pharmacy department

St. Antonius Hospital

c.knibbe@antoniusziekenhuis.nl+31306092612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026