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Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries.
Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events.
The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEA | Experimental | Administration of PEA from 8 days before surgical operation until 30 days after surgery. |
|
| Sugar pill | Active Comparator | Administration of placebo from 8 days before surgical operation until 30 days after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palmitoylethanolamide | Dietary Supplement | Before surgery: 600 mg cp twice a day After surgery: 600 mg microgranules twice a day for 10 days then 600 mg cps once a day for 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of chronic post-surgical pain | Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound. | 2 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Rinaldi, MD | Contact | 0390594224896 | rinaldi.laura@unimore.it | |
| Lara Donno, MD | Contact | 0390594224896 | l.donna@hotmail.it |
| Name | Affiliation | Role |
|---|---|---|
| Laura Rinaldi, MD | Azienda Ospedaliero-Universitaria Policlinico di Modena | Principal Investigator |
| Alberto Pasetto, PhD | Azienda Ospedaliero-Universitaria Policlinico di Modena | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Policlinico di Modena | Modena | Modena | 41100 | Italy |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C005958 | palmidrol |
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| Placebo | Dietary Supplement | Before surgery: 1 sugar pill twice a day for 8 days After surgery: 1 sugar microgranules twice a day for 10 days then 1 sugar pill once a day for 20 days |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |