Intraoperative Local Anaesthetic and Postoperative Pain

Study Overview
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Brief Summary
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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 .

Official Title
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Intraoperative Wound Infiltration With Local Anaesthetic in Surgical Patients; Is There Any Late Effect on the Postoperative Pain and the Requirements of Analgesia ? A Randomized Control Trial.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Wound infiltration with local anaesthetic
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervetional group (local anaesthetic)<br>intraoperative wound infiltration with ropivacaine 10%. | Procedure: Wound infiltration with local anaesthetic<br> <br> Drug: Ropivacaine<br> <br> |
| No Intervention: control (no local anesthetic)<br>no infiltration of the wound with local anaesthetic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six days |