Clinical trial NCT02031016: Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Sternotomy
Remifentanil
Fentanyl
Keywords: Chronic thoracic pain
Remifentanil
Fentanyl
sternotomy
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Chronic thoracic pain
timeFrame: 1 year
Secondary outcomes:
measure: Chronic thoracic pain
timeFrame: 3 and 6 months
measure: Mean Numerical Rating Scale (NRS) score
timeFrame: 3, 6 and 12 months
measure: Quality of life
timeFrame: 3, 6 and 12 months
measure: Thermal detection and pain thresholds
timeFrame: preoperative, 3 days postoperative and 1 year after surgery
measure: Pain variability
timeFrame: preoperative, 3 days and 1 year postoperative
measure: Use of analgesics during and after hospitalization
timeFrame: 3 days during hospitalization and 3,6,12 months post surgery
measure: Genetic variances
timeFrame: Blood sample at time of surgery
measure: Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications
timeFrame: 1 year after surgery
measure: Mean pain NRS (Numerical Rating Scale)
timeFrame: 3-5 days during hospitalization
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: St. Antonius Hospital
name: CAJ Knibbe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.