Status:
COMPLETED
Hyperalgesia, Persistent Pain, and Fentanyl Dosing in On-Pump Coronary Artery Bypass Grafting
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Hyperalgesia
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized, double-blinded, three arm study in adult patients undergoing first time coronary artery bypass grafting (CABG) surgery with median sternotomy. The investigators will examine the effects of...
Detailed Description
A prospective, randomized, double-blinded (patient, anesthesiologist, assessor) clinical study. This study will examine three different clinically used application schemes of fentanyl, an opioid used ...
Eligibility Criteria
Inclusion
- Consenting patients aged ≥18 years
- Undergoing first-time, elective, on-pump CABG surgery with median sternotomy and central cannulation.
Exclusion
- 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
- Pregnancy
- 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
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03450161
Start Date
May 14 2018
End Date
January 9 2021
Last Update
September 19 2024
Active Locations (1)
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1
University Hospital Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000