NCT01491191

Palmitoylethanolamide for Post-operative Pain Prevention

Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Post-operative Pain

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-12-13
• Last updated: 2011-12-13

Locations

1 site across 1 country: Italy