A Randomised Clinical Trial Evaluating the Effect of Remifentanil vs Fentanyl During Cardiac Surgery on the Incidence of Chronic Thoracic Pain
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- St. Antonius Hospital
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Chronic thoracic pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Fentanyl
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: Fentanyl (Drug)
Remifentanil
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: Remifentanil (Drug)
Remifentanil
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: Fentanyl (Drug)
Outcomes
Primary Outcomes
Chronic thoracic pain
Time Frame: 1 year
The percentage of patients reporting chronic thoracic pain one year after cardiac surgery.
Secondary Outcomes
- Genetic variances(Blood sample at time of surgery)
- Chronic thoracic pain(3 and 6 months)
- Use of analgesics during and after hospitalization(3 days during hospitalization and 3,6,12 months post surgery)
- Total medical costs and productivity costs during one year, including costs of hospitalization days (ICU and non-ICU) and costs of medications(1 year after surgery)
- Thermal detection and pain thresholds(preoperative, 3 days postoperative and 1 year after surgery)
- Mean Numerical Rating Scale (NRS) score(3, 6 and 12 months)
- Pain variability(preoperative, 3 days and 1 year postoperative)
- Quality of life(3, 6 and 12 months)
- Mean pain NRS (Numerical Rating Scale)(3-5 days during hospitalization)
Investigators
Catherijne Knibbe
Prof. Dr.
St. Antonius Hospital