Chronic Post-operative PainPEAforCPSPNCT01491191
Palmitoylethanolamide for Post-operative Pain Prevention
A study testing Palmitoylethanolamide in people with Chronic Post-operative Pain, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Post-operative Pain
- What is being tested?
- Palmitoylethanolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective gynecological or urological surgical procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Modena, 41100
Laura Rinaldi, MD
Lara Donno, MD
About this study
Official title: Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.
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.
- Conditions
- Chronic Post-operative Pain
- Being tested
- Palmitoylethanolamide, Placebo
- Keywords
- surgical pain, chronic pain, prevention, palmitoylethanolamide
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalmitoylethanolamideDietary 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
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| PEA | Experimental | Administration of PEA from 8 days before surgical operation until 30 days after surgery. Receives: Dietary Supplement: Palmitoylethanolamide |
| Sugar pill | Active comparator | Administration of placebo from 8 days before surgical operation until 30 days after surgery. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Rinaldi, University of Modena and Reggio Emilia
- Investigators
- Laura Rinaldi, MD, Principal investigator, Azienda Ospedaliero-Universitaria Policlinico di ModenaAlberto Pasetto, PhD, Study director, Azienda Ospedaliero-Universitaria Policlinico di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491191
- Sponsor's protocol ID
- 213/11
- Acronym
- PEAforCPSP
- Status last verified
- Dec 2011
- First submitted
- 9 Dec 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.
- ClinicalTrials.gov ID
- NCT01491191
- Acronym / sponsor ID
- PEAforCPSP / 213/11
- Conditions
- Chronic Post-operative Pain
- Keywords
- surgical pain, chronic pain, prevention, palmitoylethanolamide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEA | Experimental | Dietary Supplement: PalmitoylethanolamideAdministration of PEA from 8 days before surgical operation until 30 days after surgery. |
| Sugar pill | Active comparator | Dietary Supplement: PlaceboAdministration of placebo from 8 days before surgical operation until 30 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective gynecological or urological surgical procedures
Key exclusion criteria (6 listed)
- age < 18
- pregnancy or nursing
- pre-existing chronic pain
- severe hepatic or renal failure
- post-operative progression of local cancer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalmitoylethanolamideBefore 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 | Dietary supplement | PEA |
| PlaceboBefore 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 | Dietary supplement | Sugar pill |
Primary outcome
Reduction of chronic post-surgical pain
Time frame: 2 months after surgery
Assessment of pain persisting in surgical site after uncomplicated postoperative healing. Assessment of skin hyperalgesia about the surgical wound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Rinaldi, MD principal investigator
Azienda Ospedaliero-Universitaria Policlinico di Modena
Alberto Pasetto, PhD study director
Azienda Ospedaliero-Universitaria Policlinico di Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitoylethanolamide in people with Chronic Post-operative Pain, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Rinaldi, MD (0390594224896, rinaldi.laura@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of chronic post-surgical pain (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.