Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

Chronic Pain Clinical Trial

— REFLECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031016
• Other study ID #: REFLECT study
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: October 15, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chest Pain
• Chronic Pain
• Fentanyl
• Remifentanil
• Sternotomy

Intervention

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.
• 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.
• Fentanyl
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic thoracic pain	The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.	1 year	No
Secondary	Chronic thoracic pain	The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery	3 and 6 months	No
Secondary	Mean Numerical Rating Scale (NRS) score	The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.	3, 6 and 12 months	No
Secondary	Quality of life	The quality of life (QoL) three months, six months and one year after surgery.	3, 6 and 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Mean pain NRS (Numerical Rating Scale)	Mean NRS score during intensive care unit (ICU) stay and hospitalization.	3-5 days during hospitalization	No

External Links

•   Study protocol