Intraoperative Local Anaesthetic and Postoperative Pain

Hellenic Red Cross Hospital400 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Postoperative Pain

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intensity of postoperative pain

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

Time frame: six days

Secondary Outcomes

Quantity and quality of the required postoperative analgesia

Nonsteroidal antiinflamatory drugs and opioids . each day the analgesia required by the patient is recorded and classified accordingly