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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervetional group (local anaesthetic) | Experimental | intraoperative wound infiltration with ropivacaine 10%. |
|
| control (no local anesthetic) | No Intervention | no infiltration of the wound with local anaesthetic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound infiltration with local anaesthetic | Procedure |
| ||
| Ropivacaine |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| type of analgesia required postoperatively | whether more NSAIS or more opioids were required at any given day | six days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Korgialenio-Benakio", Hellenic Red Cross Athens General Hospital, Greece | Athens | 11526 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19672167 | Background | Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a. | |
| 26074287 | Derived | Lanitis S, Karkoulias K, Sgourakis G, Brotzakis P, Armoutides V, Karaliotas C. The late effect of intraoperative wound infiltration with local anaesthetic in surgical patients; is there any? A randomized control trial. Int J Surg. 2015 Aug;20:35-40. doi: 10.1016/j.ijsu.2015.05.053. Epub 2015 Jun 11. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
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| Drug |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |