perioperative pain, sternotomy, cryo-nerve blockade
Conditions
Interventions
Group 1: 50 patients receiving sternotomy with painkiller treatment and cryo-nerve blockade
Group 2: control group 50 patients receiving sternotomy with painkiller treatment but without cryo-nerve blo
Sponsors
Justus Liebig Universität Gießen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: all-comers patients undergoing coronary bypass and / or aortic valve procedures via full sternotomy
Exclusion criteria
Exclusion criteria: Patients younger than 18 years Patients with thoracic or pectoral malformations (i.e. pectus excavatum, kyphosis) Patients with known painkiller abuse or opioid abuse Patients with painkiller allergies Patients with combination procedures Patients unable to give informed written consent Patients with contraindications to painbuster intake Patients unable to take part in telephone follow ups Patients with lactation or pregnancy Patients with COPD Gold III or IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Pain-symptoms: standardized pain quantification at baseline and during the follow-up visits (e.g., at day -1, pod1-10, pod30, pod90 and pod180) using a paper-based format on the visual analogue scale -Pain-killer-consumption (measured and documented prospectively; opioid consumption is measured in milligrams of oral morphine equivalents and daily use of non-opioid painkillers is recorded) -Signs of discomfort due to hypoaesthesia using a standardized discomfort quantification at baseline and during the follow-up visits (e.g., at day -1, pod1-10, pod30, pod90 and pod180) using a paper-based format | — |
Secondary
| Measure | Time frame |
|---|---|
| -Therapeutic safety -Physical and psychological rehabilitation (SF 12 questionnaires before the intervention (at baseline) and during the follow-up visits (e.g., at pod 10, pod30, pod90 and pod180)) -quality of life (EuroQol 5D-5L questionnaires) before the intervention (at baseline) and during the follow-up visits (e.g., at 7 days, 30 days) -perioperative morbidity (MACCE, bleeding, wound healing disorders, re-operation, length of ventilation, length of ICU-stay, gastrointestinal disorders, blood-cell-count- disorders) -delirium (preoperative scanning and postoperative questionnaire at each postoperative day up to pod10) “Confusion Assessment Method for the ICU (CAM ICU)" -effects on transitional pain -effects on chronic pain | — |
Countries
Germany
Contacts
Public ContactBernd Niemann
Justus Liebig Universität Gießen
Outcome results
None listed