EUCTR2017-003278-15-BE
Active, not recruiting
Phase 1
Hyperalgesia, Persistent Pain, and Fentanyl Dosing in On-Pump Coronary Artery Bypass Grafting
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ghent University Hospital
- Enrollment
- 69
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consenting patients aged \=18 years
- •Undergoing first\-time, elective, on\-pump CABG surgery with median sternotomy and central cannulation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 46
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 23
Exclusion Criteria
- •Documentation of preexisting chronic pain as per electronic record
- •Use of opioids in the last 30 days or history/documentation of opioid abuse as per electronic record
- •BMI \> 35kg/m2 or history of obstructive sleep apnea syndrome
- •Patients with renal failure (clearance \< 30 ml/min)
- •Neuraxial anesthesia
- •Planned wound infiltration with local anesthetics
- •Known drug allergies or intolerance to fentanyl or other opioids
- •Expected to be unable to understand pinprick/allodynia testing / follow\-up questions
Outcomes
Primary Outcomes
Not specified
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