Palmitoylethanolamide for Post-operative Pain Prevention
PEAforCPSP
Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2011
CompletedFirst Posted
Study publicly available on registry
December 13, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 13, 2011
December 1, 2011
1.5 years
December 9, 2011
December 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of chronic post-surgical pain
Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.
2 months after surgery
Study Arms (2)
PEA
EXPERIMENTALAdministration of PEA from 8 days before surgical operation until 30 days after surgery.
Sugar pill
ACTIVE COMPARATORAdministration of placebo from 8 days before surgical operation until 30 days after surgery.
Interventions
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
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 Criteria
You may qualify if:
- patients undergoing elective gynecological or urological surgical procedures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Modena, 41100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Rinaldi, MD
Azienda Ospedaliero-Universitaria Policlinico di Modena
- STUDY DIRECTOR
Alberto Pasetto, PhD
Azienda Ospedaliero-Universitaria Policlinico di Modena
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
December 9, 2011
First Posted
December 13, 2011
Study Start
January 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 13, 2011
Record last verified: 2011-12