Palmitoylethanolamide for Post-operative Pain Prevention

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01491191

Acronym

PEAforCPSP

Enrollment

300

Registered

2011-12-13

Start date

2012-01-31

Completion date

2013-07-31

Last updated

2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post-operative Pain

Keywords

surgical pain, chronic pain, prevention, palmitoylethanolamide

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.

Interventions

DIETARY_SUPPLEMENTPalmitoylethanolamide

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_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactLaura Rinaldi, MD

rinaldi.laura@unimore.it0390594224896

Backup ContactLara Donno, MD

l.donna@hotmail.it0390594224896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026