Palmitoylethanolamide for Post-operative Pain Prevention

Not Applicable

• Conditions: Chronic Post-operative Pain
• Interventions: Dietary Supplement: Palmitoylethanolamide; Dietary Supplement: Placebo

• Registration Number: NCT01491191
• Lead Sponsor: University of Modena and Reggio Emilia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-12
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-12
• Last Update Submitted: 2011-12-12
• Study First Posted: 2011-12-13
• Last Update Posted: 2011-12-13
• Study Start: 2012-01
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEA	Palmitoylethanolamide	Administration of PEA from 8 days before surgical operation until 30 days after surgery.
Sugar pill	Placebo	Administration of placebo from 8 days before surgical operation until 30 days after surgery.

Primary Outcome Measures

Name	Time	Method
Reduction of chronic post-surgical pain	2 months after surgery	Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy