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

October 15, 2016 updated by: Catherijne Knibbe, St. Antonius Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Sublimaze
Drug: Fentanyl
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
Other Names:
  • 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: 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 Names:
  • Sublimaze
Drug: Fentanyl
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
Other Names:
  • Sublimaze
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 Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic thoracic pain
Time Frame: 1 year
The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 and 6 months
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, 6 and 12 months
Quality of life
Time Frame: 3, 6 and 12 months
The quality of life (QoL) three months, six months and one year after surgery.
3, 6 and 12 months
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)
preoperative, 3 days postoperative and 1 year after surgery
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.
preoperative, 3 days and 1 year postoperative
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;
3 days during hospitalization and 3,6,12 months post surgery
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))
Blood sample at time of surgery
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
1 year after surgery
Mean pain NRS (Numerical Rating Scale)
Time Frame: 3-5 days during hospitalization
Mean NRS score during intensive care unit (ICU) stay and hospitalization.
3-5 days during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: CAJ Knibbe, Prof. Dr., St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 15, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REFLECT study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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