Hyperalgesia, Persistent Pain, and Fentanyl Dosing in On-Pump Coronary Artery Bypass Grafting

Phase 1

• Conditions: Secondary wound hyperalgesia Persistent Pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003278-15-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 69

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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified