Palmitoylethanolamide for Post-operative Pain Prevention (PEAforCPSP)
|ClinicalTrials.gov Identifier: NCT01491191|
Recruitment Status : Unknown
Verified December 2011 by Laura Rinaldi, University of Modena and Reggio Emilia.
Recruitment status was: Not yet recruiting
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Post-operative Pain||Dietary Supplement: Palmitoylethanolamide Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Administration of PEA from 8 days before surgical operation until 30 days after surgery.
Dietary Supplement: Palmitoylethanolamide
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
Active Comparator: Sugar pill
Administration of placebo from 8 days before surgical operation until 30 days after surgery.
Dietary Supplement: Placebo
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
- Reduction of chronic post-surgical pain [ Time Frame: 2 months after surgery ]Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491191
|Contact: Laura Rinaldi, MDemail@example.com|
|Contact: Lara Donno, MDfirstname.lastname@example.org|
|Azienda Ospedaliero-Universitaria Policlinico di Modena||Not yet recruiting|
|Modena, Italy, 41100|
|Principal Investigator: Laura Rinaldi, MD|
|Sub-Investigator: Lara Donno, MD|
|Principal Investigator:||Laura Rinaldi, MD||Azienda Ospedaliero-Universitaria Policlinico di Modena|
|Study Director:||Alberto Pasetto, PhD||Azienda Ospedaliero-Universitaria Policlinico di Modena|