We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below Knee Fracture Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05317676
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : April 8, 2022
Sponsor:
Collaborator:
GE Nutrients Inc. (Gencor)
Information provided by (Responsible Party):
Ariana M. Nelson, University of California, Irvine

Brief Summary:
Palmitoylethanolamide (PEA), a non-psychoactive cannabis compound derived from peanuts, egg yolks, and soybeans, is an Endogenous FA Amide produced in the body as a biological response and a repair mechanism in chronic inflammation and chronic pain. In animal and clinical trials, PEA has also shown evidence of pain reduction, sleep improvement, and increased joint mobility and function with minimal side-effects. The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed.

Condition or disease Intervention/treatment Phase
Tibial Fractures Fibula Fracture Knee Fracture Drug: Palmitoylethanolamide Drug: Placebo Phase 2

Detailed Description:

According to the National Center for Health Statistics, the United States sees approximately 492,000 tibial fractures per year. Of that population, there are greater than 70,000 hospitalizations, 800,000 office visits, and 500,000 hospital days attributed annually. This does not include the approximately 250,000 proximal femur fractures that occur in the US annually, which is expected to double by 2050. There are also over 5 million ankle injuries in the US per year at a rate of approximately 187 ankle fractures per 100,000 people. To repair these below knee fractures, patients with severe cases often have an open reduction and internal fixation (ORIF) surgery to stabilize and heal the broken bone.

On average, these patients are seen by physical therapy to determine their safety for going home and if they need any equipment like a walker or crutches. They are discharged with pain medications, such as analgesic opioids and stool softeners. These patients return to clinic in 2 weeks for follow up which involves an exam, suture removal, x-rays, and possibly weight bearing status update. They then return in 1 month for exam, x-rays, and weightbearing status. Finally they return at 3 months for exam, x-rays, and weightbearing status.

The study team intends to study whether the inclusion of PEA in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Postoperative Pain and Inflammation Following Below Knee Fracture Fixation: A Pilot Study.
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Palmitoylethanolamide
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
Drug: Palmitoylethanolamide
2-month supply of PEA will be given upon discharge. 300mg will be taken twice a day in conjunction with discharge medications (opioid and NSAIDs).
Other Names:
  • PEA
  • GenCor

Placebo Comparator: Placebo
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge
Drug: Placebo
2-month supply of placebo will be given upon discharge. Placebo will taken twice a day in conjunction with discharge medications (opioid and NSAIDs).




Primary Outcome Measures :
  1. 3 month post-surgical Opioid use Questionnaire [ Time Frame: 3 months ]
    Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with opioid prescription in chart

  2. 3 month post-surgical NSAID use Questionnaire [ Time Frame: 3 months ]
    Questionnaire (during call) asking patient for list of medications taken in last 2 days and cross referencing with NSAID prescription in chart


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 3 months ]
    Pain scores using McGill Pain Questionnaire; minimum pain score: 0 (would not be seen in a person with true pain);maximum pain score: 78;The higher the pain score the greater the pain.

  2. Pain Interference [ Time Frame: 3 months ]
    Pain interference using PROMIS Pain Interference Survey; Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 6-item form, the lowest possible raw score is 6; the highest possible raw score is 30.Locate the applicable score conversion table and use this table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10

  3. Average Pain Scores [ Time Frame: 3 months ]
    Pain scores using Brief Pain Inventory; 0-10 numerical rating scale used to measure three pain severity items: "worst" in the past month, "average," and "now," where 0=no pain and 10=pain as bad as you can imagine.

  4. Functional Status [ Time Frame: 3 months ]
    Functional status using PROMIS Physical Function Survey; The PF-10a is a 10-item questionnaire assessing current self-reported physical function. Raw scores range from 10 to 50 and can be translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean; for this study, all reported PF-10a scores are T-scores.

  5. Post-Surgical Complications [ Time Frame: 3 months ]
    Any complications following surgery

  6. Medication Adverse Events [ Time Frame: 3 months ]
    Any adverse events to study drug and post-surgical medications given at discharge

  7. Average Pain Interference [ Time Frame: 3 months ]
    Pain interference using Brief Pain Inventory; 0-10 numerical rating scale used to measure three pain severity items: "worst" in the past month, "average," and "now," where 0=no pain and 10=pain as bad as you can imagine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Has an isolated below knee orthopaedic injury without any neurovascular injury involvement
  • Has an isolated active orthopaedic injury
  • Females of childbearing potential must have a negative urine and blood pregnancy test at Screening and a negative urine pregnancy test on Day 1 before study drug is administered. Females must abstain from sex or use a highly effective method of contraception during the period from Screening to administration of study drug and for 30 days after the last dose of study medication. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom with spermicide, vasectomy, intrauterine device.
  • If females are of non-child bearing potential, they must be post-menopausal defined as: age > 55 with no menses within the past 12 months or history of hysterectomy, or history of bilateral oophorectomy, or bilateral tubal ligation.

Exclusion Criteria:

  • Less than 18 years of age
  • Pregnant or Breastfeeding
  • Allergic to cannabis
  • History of chronic opioid use
  • History of substance abuse
  • History of chronic use of cannabis products of any kind
  • Has multiple active orthopaedic injuries
  • Has neurovascular injury associated with your orthopaedic injury
  • History of a syndrome that causes chronic pain (i.e. fibromuscular dysplasia, complex pain syndrome)
  • History of peripheral neuropathy
  • History of diagnosed psychiatric illness
  • ASA score of greater than 3
  • Clinically significant unstable medical condition, including but not limited to cardiovascular, neurologic, psychiatric, endocrine, hepatic, and renal disorders.
  • Allergy to palmitoylethanolamide (PEA) or its derivatives such as soy or eggs
  • AST/ALT ≥3x ULN and/or bilirubin ≥2x ULN at screening.
  • Abnormal creatinine or renal function abnormalities.
  • Have end stage organ failure (Cardiac, Renal, or Hepatic)
  • Currently undergoing addiction/detoxification therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05317676


Contacts
Layout table for location contacts
Contact: Joseph Tafalla, MS 562-229-8926 jtafalla@hs.uci.edu
Contact: Jamie Ahn jkahn1@hs.uci.edu

Locations
Layout table for location information
United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Joseph Tafalla, MS    562-229-8926    jtafalla@hs.uci.edu   
Principal Investigator: Ariana Nelson, MD         
Sponsors and Collaborators
University of California, Irvine
GE Nutrients Inc. (Gencor)
Investigators
Layout table for investigator information
Principal Investigator: Ariana Nelson, MD Associate Clinical Professor
Publications:
Grotenhermen F. Cannabinoids and the endocannabinoid system. Cannabinoids.2006;1:10-14.

Layout table for additonal information
Responsible Party: Ariana M. Nelson, Associate Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05317676    
Other Study ID Numbers: 2020-6007
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ariana M. Nelson, University of California, Irvine:
Palmitoylethanolamide
Open reduction and internal fixation (ORIF) Surgery
Postoperative Pain
Inflammation
Reduce Opioid Consumption
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries
Palmidrol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists