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Chronic PainPhase 4REFLECTNCT02031016

Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

A Phase 4 study testing Fentanyl and Remifentanil in people with Chronic Pain and Sternotomy, run by St. Antonius Hospital at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Pain, Sternotomy, Remifentanil
What is being tested?
Fentanyl and Remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteNetherlands
Study dates
Feb 2014to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • St. Antonius Hospital

    Nieuwegein

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Fentanyl, Remifentanil
Keywords
Chronic thoracic pain, Remifentanil, Fentanyl, sternotomy
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FentanylDrug

    Also called Sublimaze

    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.

  • RemifentanilDrug

    Also called Ultiva

    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.

  • FentanylDrug

    Also called Sublimaze

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

Study groups in NCT02031016
Study groupRoleWhat they receive
FentanylActive comparatorfentanyl 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.
Receives: Drug: Fentanyl
RemifentanilActive comparatorremifentanil, 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.
Receives: Drug: Remifentanil; Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic thoracic pain

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

    Measured: 1 year

Secondary outcomes (9)

  1. Chronic thoracic pain

    The percentage of patients reporting chronic thoracic pain three months and six months after cardiac surgery

    Measured: 3 and 6 months

  2. Mean Numerical Rating Scale (NRS) score

    The mean NRS score of patients with chronic thoracic pain three months and six months after cardiac surgery.

    Measured: 3, 6 and 12 months

  3. Quality of life

    The quality of life (QoL) three months, six months and one year after surgery.

    Measured: 3, 6 and 12 months

  4. 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)

    Measured: preoperative, 3 days postoperative and 1 year after surgery

  5. 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.

    Measured: preoperative, 3 days and 1 year postoperative

  6. 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;

    Measured: 3 days during hospitalization and 3,6,12 months post surgery

  7. 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))

    Measured: Blood sample at time of surgery

  8. Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications

    Measured: 1 year after surgery

  9. Mean pain NRS (Numerical Rating Scale)

    Mean NRS score during intensive care unit (ICU) stay and hospitalization.

    Measured: 3-5 days during hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031016
Sponsor's protocol ID
REFLECT study
Acronym
REFLECT
Status last verified
Oct 2016
First submitted
16 Dec 2013
Last updated
18 Oct 2016
Results posted
No

Publications

  • 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.

    PubMed 30211725

  • 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.

    PubMed 28741894

  • 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.

    PubMed 25429720

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fentanyl and Remifentanil in people with Chronic Pain and Sternotomy, run by St. Antonius Hospital at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic thoracic pain (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02031016, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.

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