Palmitoylethanolamide for Post-operative Pain Prevention

Chronic Post-operative Pain Clinical Trial

— PEAforCPSP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01491191
• Other study ID #: 213/11
• Status: Not yet recruiting
• Phase: N/A
• First received: December 9, 2011
• Last updated: December 12, 2011
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2011
• Source: University of Modena and Reggio Emilia
• Contact: Laura Rinaldi, MD
• Phone: 0390594224896
• Email: rinaldi.laura[@]unimore.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing elective gynecological or urological surgical procedures

Exclusion Criteria:

• age < 18

• pregnancy or nursing

• pre-existing chronic pain

• severe hepatic or renal failure

• post-operative progression of local cancer disease

• post-operative infection or inflammation of surgical wound

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Post-operative Pain
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No