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Palmitoylethanolamide for Post-operative Pain Prevention (PEAforCPSP)

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ClinicalTrials.gov Identifier: NCT01491191
Recruitment Status : Unknown
Verified December 2011 by Laura Rinaldi, University of Modena and Reggio Emilia.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Laura Rinaldi, 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.


Condition or disease Intervention/treatment
Chronic Post-operative Pain Dietary Supplement: Palmitoylethanolamide Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.
Study Start Date : January 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: PEA
Administration of PEA from 8 days before surgical operation until 30 days after surgery.
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
Active Comparator: Sugar pill
Administration of placebo from 8 days before surgical operation until 30 days after surgery.
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



Primary Outcome Measures :
  1. Reduction of chronic post-surgical pain [ Time Frame: 2 months after surgery ]
    Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491191


Contacts
Contact: Laura Rinaldi, MD 0390594224896 rinaldi.laura@unimore.it
Contact: Lara Donno, MD 0390594224896 l.donna@hotmail.it

Locations
Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena Not yet recruiting
Modena, Italy, 41100
Principal Investigator: Laura Rinaldi, MD         
Sub-Investigator: Lara Donno, MD         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Principal Investigator: Laura Rinaldi, MD Azienda Ospedaliero-Universitaria Policlinico di Modena
Study Director: Alberto Pasetto, PhD Azienda Ospedaliero-Universitaria Policlinico di Modena

Responsible Party: Laura Rinaldi, Medical Doctor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01491191     History of Changes
Other Study ID Numbers: 213/11
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Laura Rinaldi, University of Modena and Reggio Emilia:
surgical pain
chronic pain
prevention
palmitoylethanolamide

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists