Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below Knee Fracture Fixation
NCT ID: NCT05317676
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2023-05-31
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF
NCT04768478
Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
NCT02967172
Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)
NCT01789216
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
NCT01328782
Randomized Controlled Trial for Ankle Fracture Pain Control
NCT03696199
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Palmitoylethanolamide
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
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).
Placebo
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GE Nutrients Inc. (Gencor)
UNKNOWN
University of California, Irvine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ariana M. Nelson
Associate Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ariana Nelson, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC Irvine Medical Center
Orange, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Artukoglu BB, Beyer C, Zuloff-Shani A, Brener E, Bloch MH. Efficacy of Palmitoylethanolamide for Pain: A Meta-Analysis. Pain Physician. 2017 Jul;20(5):353-362.
Grotenhermen F. Cannabinoids and the endocannabinoid system. Cannabinoids.2006;1:10-14.
Martin-Sanchez E, Furukawa TA, Taylor J, Martin JL. Systematic review and meta-analysis of cannabis treatment for chronic pain. Pain Med. 2009 Nov;10(8):1353-68. doi: 10.1111/j.1526-4637.2009.00703.x. Epub 2009 Sep 1.
Cabral GA, Griffin-Thomas L. Emerging role of the cannabinoid receptor CB2 in immune regulation: therapeutic prospects for neuroinflammation. Expert Rev Mol Med. 2009 Jan 20;11:e3. doi: 10.1017/S1462399409000957.
Calignano A, La Rana G, Giuffrida A, Piomelli D. Control of pain initiation by endogenous cannabinoids. Nature. 1998 Jul 16;394(6690):277-81. doi: 10.1038/28393.
Calignano A, La Rana G, Piomelli D. Antinociceptive activity of the endogenous fatty acid amide, palmitylethanolamide. Eur J Pharmacol. 2001 May 11;419(2-3):191-8. doi: 10.1016/s0014-2999(01)00988-8.
Esposito E, Paterniti I, Mazzon E, Genovese T, Di Paola R, Galuppo M, Cuzzocrea S. Effects of palmitoylethanolamide on release of mast cell peptidases and neurotrophic factors after spinal cord injury. Brain Behav Immun. 2011 Aug;25(6):1099-112. doi: 10.1016/j.bbi.2011.02.006. Epub 2011 Feb 25.
Luongo L, Guida F, Boccella S, Bellini G, Gatta L, Rossi F, de Novellis V, Maione S. Palmitoylethanolamide reduces formalin-induced neuropathic-like behaviour through spinal glial/microglial phenotypical changes in mice. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):45-54. doi: 10.2174/1871527311312010009.
Scuderi C, Steardo L. Neuroglial roots of neurodegenerative diseases: therapeutic potential of palmitoylethanolamide in models of Alzheimer's disease. CNS Neurol Disord Drug Targets. 2013 Feb 1;12(1):62-9. doi: 10.2174/1871527311312010011.
Nau R, Djukic M, Spreer A, Ribes S, Eiffert H. Bacterial meningitis: an update of new treatment options. Expert Rev Anti Infect Ther. 2015;13(11):1401-23. doi: 10.1586/14787210.2015.1077700. Epub 2015 Aug 18.
Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol. 2016 Oct;82(4):932-42. doi: 10.1111/bcp.13020. Epub 2016 Jun 29.
COBURN AF, GRAHAM CE, HANINGER J. The effect of egg yolk in diets on anaphylactic arthritis (passive Arthus phenomenon) in the guinea pig. J Exp Med. 1954 Nov 1;100(5):425-35. doi: 10.1084/jem.100.5.425.
Hesselink JM. Evolution in pharmacologic thinking around the natural analgesic palmitoylethanolamide: from nonspecific resistance to PPAR-alpha agonist and effective nutraceutical. J Pain Res. 2013 Aug 8;6:625-34. doi: 10.2147/JPR.S48653. eCollection 2013.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-6007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.