Palmitoylethanolamide for Post-operative Pain Prevention (PEAforCPSP)

University of Modena and Reggio Emilia

Status: Unknown

Conditions: Chronic Post-operative Pain

Treatments: Dietary Supplement: Palmitoylethanolamide; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01491191

213/11

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

PEA

Experimental group

Description:

Administration of PEA from 8 days before surgical operation until 30 days after surgery.

Treatment:

Dietary Supplement: Palmitoylethanolamide

Sugar pill

Active Comparator group

Description:

Administration of placebo from 8 days before surgical operation until 30 days after surgery.

Treatment:

Dietary Supplement: Placebo