Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

NCT02031016 | Completed Phase 4

• 1 other identifier: REFLECT study
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Sternotomy; Remifentanil; Fentanyl

Keywords

Chronic thoracic pain; Remifentanil; Fentanyl; sternotomy

Outcome Measures

Primary Outcomes (1)

• Chronic thoracic pain

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

  1 year

Secondary Outcomes (9)

• Chronic thoracic pain

  3 and 6 months

• Mean Numerical Rating Scale (NRS) score

  3, 6 and 12 months

• Quality of life

  3, 6 and 12 months

• Thermal detection and pain thresholds

  preoperative, 3 days postoperative and 1 year after surgery

• Pain variability

  preoperative, 3 days and 1 year postoperative

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

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

Remifentanil

ACTIVE COMPARATOR

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: Remifentanil; Drug: Fentanyl

Interventions

Fentanyl DRUG

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.

Also known as: Sublimaze

Fentanyl

Remifentanil DRUG

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.

Also known as: Ultiva

Remifentanil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 30211725 DERIVED

• 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.

  PMID: 28741894 DERIVED

• 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.

  PMID: 25429720 DERIVED

Related Links

• Study protocol

MeSH Terms

Conditions

Chronic Pain

Interventions

Fentanyl; Remifentanil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• CAJ Knibbe, Prof. Dr.

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 9, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

NL (1)