Palmitoylethanolamide for Post-operative Pain Prevention (PEAforCPSP)
This study is not yet open for participant recruitment.
Verified December 2011 by University of Modena and Reggio Emilia
Sponsor:
University of Modena and Reggio Emilia
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
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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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| 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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms Palmidrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antiviral Agents Anti-Infective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013