Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

Phase 4

Completed

• Conditions: Sternotomy; Fentanyl; Chronic Pain; Remifentanil
• Interventions: Drug: Remifentanil; Drug: Fentanyl

• Registration Number: NCT02031016
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Study Start: 2014-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-15
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil	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.
Remifentanil	Fentanyl	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.
Fentanyl	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.

Primary Outcome Measures

Name	Time	Method
Chronic thoracic pain	1 year	The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
Genetic variances	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))
Chronic thoracic pain	3 and 6 months	The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery
Use of analgesics during and after hospitalization	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;
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
Thermal detection and pain thresholds	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)
Mean Numerical Rating Scale (NRS) score	3, 6 and 12 months	The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.
Pain variability	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.
Quality of life	3, 6 and 12 months	The quality of life (QoL) three months, six months and one year after surgery.
Mean pain NRS (Numerical Rating Scale)	3-5 days during hospitalization	Mean NRS score during intensive care unit (ICU) stay and hospitalization.

Trial Locations

Locations (1)

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands