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

Primary Purpose

Chronic Pain, Sternotomy, Remifentanil

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Fentanyl
Remifentanil
Fentanyl
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain focused on measuring Chronic thoracic pain, Remifentanil, Fentanyl, sternotomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fentanyl

Remifentanil

Arm Description

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/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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Chronic thoracic pain
The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery
Mean Numerical Rating Scale (NRS) score
The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.
Quality of life
The quality of life (QoL) three months, six months and one year after surgery.
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)
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.
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;
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))
Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications
Mean pain NRS (Numerical Rating Scale)
Mean NRS score during intensive care unit (ICU) stay and hospitalization.

Full Information

First Posted
December 16, 2013
Last Updated
October 15, 2016
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02031016
Brief Title
Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain
Acronym
REFLECT
Official Title
A Randomised Clinical Trial Evaluating the Effect of Remifentanil vs Fentanyl During Cardiac Surgery on the Incidence of Chronic Thoracic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Sternotomy, Remifentanil, Fentanyl
Keywords
Chronic thoracic pain, Remifentanil, Fentanyl, sternotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Sublimaze
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Sublimaze
Intervention Description
fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
Primary Outcome Measure Information:
Title
Chronic thoracic pain
Description
The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Chronic thoracic pain
Description
The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery
Time Frame
3 and 6 months
Title
Mean Numerical Rating Scale (NRS) score
Description
The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.
Time Frame
3, 6 and 12 months
Title
Quality of life
Description
The quality of life (QoL) three months, six months and one year after surgery.
Time Frame
3, 6 and 12 months
Title
Thermal detection and pain thresholds
Description
The difference in postoperative pain thresholds three days and one year after cardiac surgery compared to the preoperative pain threshold (baseline)
Time Frame
preoperative, 3 days postoperative and 1 year after surgery
Title
Pain variability
Description
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.
Time Frame
preoperative, 3 days and 1 year postoperative
Title
Use of analgesics during and after hospitalization
Description
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;
Time Frame
3 days during hospitalization and 3,6,12 months post surgery
Title
Genetic variances
Description
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))
Time Frame
Blood sample at time of surgery
Title
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
Title
Mean pain NRS (Numerical Rating Scale)
Description
Mean NRS score during intensive care unit (ICU) stay and hospitalization.
Time Frame
3-5 days during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAJ Knibbe, Prof. Dr.
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
30211725
Citation
de Hoogd S, Valkenburg AJ, van Dongen EPA, Daeter EJ, van Rosmalen J, Dahan A, Tibboel D, Knibbe CAJ. Short- and long-term impact of remifentanil on thermal detection and pain thresholds after cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jan;36(1):32-39. doi: 10.1097/EJA.0000000000000887.
Results Reference
derived
PubMed Identifier
28741894
Citation
de Hoogd S, Ahlers SJGM, van Dongen EPA, van de Garde EMW, Daeter EJ, Dahan A, Tibboel D, Knibbe CAJ. Randomized Controlled Trial on the Influence of Intraoperative Remifentanil versus Fentanyl on Acute and Chronic Pain after Cardiac Surgery. Pain Pract. 2018 Apr;18(4):443-451. doi: 10.1111/papr.12615. Epub 2017 Sep 28.
Results Reference
derived
PubMed Identifier
25429720
Citation
de Hoogd S, Ahlers SJ, van Dongen EP, Tibboel D, Dahan A, Knibbe CA. Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial. Trials. 2014 Nov 27;15:466. doi: 10.1186/1745-6215-15-466.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25429720
Description
Study protocol

Learn more about this trial

Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

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