Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain

Condition(s) targeted: Chronic Pain; Sternotomy; Remifentanil; Fentanyl

Intervention: Fentanyl (Drug); Remifentanil (Drug); Fentanyl (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: St. Antonius Hospital

Official(s) and/or principal investigator(s):
CAJ Knibbe, Prof. Dr., Principal Investigator, Affiliation: St. Antonius Hospital

Overall contact:
S. de Hoogd, MSc, Phone: +3130-6093500, Email: s.de.hoogd@antoniusziekenhuis.nl

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.

Official title: A Randomised Clinical Trial Evaluating the Effect of Remifentanil vs Fentanyl During Cardiac Surgery on the Incidence of Chronic Thoracic Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Chronic thoracic pain

Secondary outcome:

Chronic thoracic pain

Mean Numerical Rating Scale (NRS) score

Quality of life

Thermal detection and pain thresholds

Pain variability

Use of analgesics during and after hospitalization

Genetic variances

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)

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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.

S. de Hoogd, MSc, Phone: +3130-6093500, Email: s.de.hoogd@antoniusziekenhuis.nl

St. Antonius Hospital, Nieuwegein, Netherlands; Recruiting
S. de Hoogd, MSc., Phone: +3130-6093500, Email: s.de.hoogd@antoniusziekenhuis.nl

Starting date: February 2014
Last updated: October 30, 2014