Secondary wound hyperalgesia Persistent Pain
Conditions
Interventions
Trade Name: Fentanyl-Janssen 0,05 mg/ml oplossing voor injectie
Product Name: Fentanyl-Janssen 0,05 mg/ml oplossing voor injectie
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FENTA
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1) to explore the intraoperative concentrations of fentanyl in these various dosing schemes during and after extracorporeal circulation (ECC). [i.e. determine the time course of fentanyl with ECC and its association with hyperalgesia; explorative] 2) to explore a possible association between fentanyl dosing, hyperalgesia, and persisting pain 3, 6, and 12 months after surgery. [i.e. clinical implication on persistent/chronic pain; explorative] ;Main Objective: to assess whether or not different intraoperative dosing schemes of fentanyl during on-pump CABG surgery influence the area of hyperalgesia as measured by sternal pin-prick testing on the first postoperative day. ;Primary end point(s): the area of hyperalgesia as determined by pin-prick testing using a von Frey filament (256mN).;Timepoint(s) of evaluation of this end point: at 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - the area of hyperalgesia - the areas of allodynia . - the highest level of pain/worst pain on the numeric rating scale (NRS) will be asked. - the morphine-equivalent opioid consumption will be ascertained. ;Timepoint(s) of evaluation of this end point: - at 48 hours - at 24 and 48 hours - for the last 24/48 hours when visited for pin-prick testing - at 24 and 48 hours | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed