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Palmitoylethanolamide for Post-operative Pain Prevention

NCT ID: NCT01491191

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Post-operative Pain

Keywords

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surgical pain chronic pain prevention palmitoylethanolamide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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PEA

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

Group Type EXPERIMENTAL

Palmitoylethanolamide

Intervention Type DIETARY_SUPPLEMENT

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

Sugar pill

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

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Modena and Reggio Emilia

OTHER

Sponsor Role lead

Responsible Party

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Laura Rinaldi

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Rinaldi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Policlinico di Modena

Alberto Pasetto, PhD

Role: STUDY_DIRECTOR

Azienda Ospedaliero-Universitaria Policlinico di Modena

Locations

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Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Modena, Italy

Site Status

Countries

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Italy

Central Contacts

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Laura Rinaldi, MD

Role: CONTACT

Phone: 0390594224896

Email: [email protected]

Lara Donno, MD

Role: CONTACT

Phone: 0390594224896

Email: [email protected]

Other Identifiers

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213/11

Identifier Type: -

Identifier Source: org_study_id