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Palmitoylethanolamide for Post-operative Pain Prevention (PEAforCPSP)

Primary Purpose

Chronic Post-operative Pain

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Palmitoylethanolamide

Placebo

About this trial

This is an interventional prevention trial for Chronic Post-operative Pain focused on measuring surgical pain, chronic pain, prevention, palmitoylethanolamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Azienda Ospedaliero-Universitaria Policlinico di Modena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEA

Sugar pill

Arm Description

Administration of PEA from 8 days before surgical operation until 30 days after surgery.

Administration of placebo from 8 days before surgical operation until 30 days after surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01491191

First Posted

December 9, 2011

Last Updated

December 12, 2011

Sponsor

University of Modena and Reggio Emilia

1. Study Identification

Unique Protocol Identification Number

NCT01491191

Brief Title

Palmitoylethanolamide for Post-operative Pain Prevention

Acronym

PEAforCPSP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Modena and Reggio Emilia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Post-operative Pain

Keywords

surgical pain, chronic pain, prevention, palmitoylethanolamide

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEA

Arm Type

Experimental

Arm Description

Administration of PEA from 8 days before surgical operation until 30 days after surgery.

Arm Title

Sugar pill

Arm Type

Active Comparator

Arm Description

Administration of placebo from 8 days before surgical operation until 30 days after surgery.

Intervention Type

Dietary Supplement

Intervention Name(s)

Palmitoylethanolamide

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Reduction of chronic post-surgical pain

Description

Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.

Time Frame

2 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Rinaldi, MD

Phone

0390594224896

rinaldi.laura@unimore.it

First Name & Middle Initial & Last Name or Official Title & Degree

Lara Donno, MD

Phone

0390594224896

l.donna@hotmail.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Rinaldi, MD

Organizational Affiliation

Azienda Ospedaliero-Universitaria Policlinico di Modena

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alberto Pasetto, PhD

Organizational Affiliation

Azienda Ospedaliero-Universitaria Policlinico di Modena

Official's Role

Study Director

Facility Information:

Facility Name

Azienda Ospedaliero-Universitaria Policlinico di Modena

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Rinaldi, MD

First Name & Middle Initial & Last Name & Degree

Lara Donno, MD

12. IPD Sharing Statement

Learn more about this trial

Palmitoylethanolamide for Post-operative Pain Prevention

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