Background
Methods/Design
Inclusion and exclusion criteria
Surgical Methods
Anaesthesiological Methods
Randomization & Blinding
-
for all patients at the completion of the final data analyses
-
for individual patients following the occurrence of adverse events requiring immediate knowledge of treatment allocation for the safety of the patient.
The Pain Matcher Device
Primary Outcome
Secondary Outcomes
Level of Pain
-
Pain Matcher®
-
VAS
-
Areas of hyperalgesia, hypaesthesia
Hospitalization
-
Length of stay (days)
-
ASA-Classification
-
Beginning of mobilisation (days)
-
Removal of drainage (days)
Function
-
Return to work or normal activity (days and %)
-
Quality of life (SF36)
Baseline | FU 1 | FU 2 | FU 3 | FU 4 | ||
---|---|---|---|---|---|---|
Consultation | Intra-/post-OP | 2 weeks | 1 month | 3 months | 12 months | |
General data
| ||||||
- Patients data | ||||||
- Informed consent | ||||||
Anaesthesiological data
| ||||||
Surgical intervention
| ||||||
Edverse events
| ||||||
Primary outomes: | ||||||
- VAS | ||||||
- Pain Matcher®
| ||||||
Secondary outcomes: |
Hypothesis
Sample size & power calculation
Group sequential design and interim analysis
Stopping rules
Interim analyses | Number of patients | Reject H0 if z ≥ | Accept H0 if z < | Reject H0 if p ≤ |
---|---|---|---|---|
1 | 120 | -2.9626 | 2.9626 | 0.0031 |
2 | 180 | -2.359 | 2.359 | 0.0183 |
3 = final analysis | 240 | -2.0141 | 2.0141 | 0.044 |