Postoperative Pain
Conditions
Brief summary
Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect. Materials and methods: We will conduct a RCT involving 400 consecutive general surgery patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period. Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .
Interventions
PROCEDUREWound infiltration with local anaesthetic
DRUGRopivacaine
Sponsors
Hellenic Red Cross Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with conditions that require surgery ( general surgery) * Must be able to comprehent the questions , fill documents, communicate well with the doctors * Patients who will have at least one surgical incision under general or regional anaesthesia
Exclusion criteria
* Patients who could not comprehend well * patients who remained intubated even for one postoperative day * Patients who were discharged the day of the operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of postoperative pain | six days | the intensity of the pain will be assessed using the : The visual analogue scale (VAS) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) and (2) the numeric rating scale (NRS) which is a segmented numeric version of the visual analog scale (VAS) in which the patient indicates the number (0-10) that best reflects the intensity of their pain. Both tests are easy to obtain, reliable, valid and can detect changes of over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity and quality of the required postoperative analgesia | six days | Nonsteroidal antiinflamatory drugs and opioids . each day the analgesia required by the patient is recorded and classified accordingly |
Other
| Measure | Time frame | Description |
|---|---|---|
| type of analgesia required postoperatively | six days | whether more NSAIS or more opioids were required at any given day |
Countries
Greece
Outcome results
None listed