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
|Condition or disease||Intervention/treatment||Phase|
|Tibial Fractures Fibula Fracture Knee Fracture||Drug: Palmitoylethanolamide Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|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|
Active Comparator: Palmitoylethanolamide
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
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 Comparator: Placebo
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge
2-month supply of placebo will be given upon discharge. Placebo will taken twice a day in conjunction with discharge medications (opioid and NSAIDs).
- 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
- 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
- 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.
- 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
- 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.
- 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.
- Post-Surgical Complications [ Time Frame: 3 months ]Any complications following surgery
- Medication Adverse Events [ Time Frame: 3 months ]Any adverse events to study drug and post-surgical medications given at discharge
- 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.
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
|Contact: Joseph Tafalla, MSfirstname.lastname@example.org|
|Contact: Jamie Ahnemail@example.com|
|United States, California|
|UC Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Joseph Tafalla, MS 562-229-8926 firstname.lastname@example.org|
|Principal Investigator: Ariana Nelson, MD|
|Principal Investigator:||Ariana Nelson, MD||Associate Clinical Professor|