Effect of Palmitoylethanolamide on Reducing Opioid Consumption for Below

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05317676
Study type	Interventional
Source	University of California, Irvine
Contact
Status	Withdrawn
Phase	Phase 2
Start date	May 2023
Completion date	December 2025

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See also
Status	Clinical Trial	Phase
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Terminated	`NCT02845245` - Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques	N/A
Completed	`NCT02456194` - Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial	N/A
Completed	`NCT01132508` - Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures	N/A
Terminated	`NCT00667849` - Trial to Evaluate UltraSound in the Treatment of Tibial Fractures	N/A
Completed	`NCT00512434` - Percutaneous Autologous Bone-marrow Grafting for Open Tibial Shaft Fracture	N/A
Completed	`NCT00161616` - Study Evaluating InductOs in Diaphyseal Tibia Fractures	Phase 4
Terminated	`NCT03881241` - Safety Study of Treatment of Leg Fractures
Completed	`NCT02750072` - INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia	N/A
Completed	`NCT04015167` - A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
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Completed	`NCT05613257` - Distal Targeter vs Free-hand	N/A
Completed	`NCT03388879` - Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures	N/A
Completed	`NCT02491047` - Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures	N/A
Completed	`NCT01797640` - Intramedullary Nailing of Tibia Fractures	N/A
Recruiting	`NCT03232216` - Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?	N/A
Withdrawn	`NCT03826784` - Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures	Phase 3
Terminated	`NCT00253981` - Light Therapy in the Treatment of Leg Pain	N/A
Completed	`NCT05303389` - Posterior Plating Versus Anterior to Posterior Screws in Fixation of Posterior Column in Pilon Fractures	N/A
Recruiting	`NCT05272631` - Depuy Synthes Lower Extremity Shaft Nail Registry

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms