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Palmitoylethanolamide for Post-operative Pain Prevention (PEAforCPSP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by University of Modena and Reggio Emilia.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Laura Rinaldi, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01491191
First received: December 9, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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 Intervention
Chronic Post-operative Pain
Dietary Supplement: Palmitoylethanolamide
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.

Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Reduction of chronic post-surgical pain [ Time Frame: 2 months after surgery ] [ Designated as safety issue: No ]
    Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491191

Locations
Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41100
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
  More Information

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 
Study First Received: December 9, 2011
Last Updated: December 12, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on December 06, 2016