MedTrace Logo

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

NCT05317676 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-09

No results posted yet for this study

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.

Conditions

  • Tibial Fractures
  • Fibula Fracture
  • Knee Fracture

Interventions

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).

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).

Sponsors & Collaborators

  • GE Nutrients Inc. (Gencor)

    collaborator UNKNOWN

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Ariana Nelson, MD · Associate Clinical Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317676 on ClinicalTrials.gov