Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture (Adult NSAID)

Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications for providing pain control in certain patients. There is some data to suggest that NSAIDs can be used to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. There are mixed results about the effect of bone healing in adult patients with broken bones. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period. Furthermore, the investigators hypothesize that patients will have similar or better patient reported outcomes, range of motion, and strength with the administration of NSAIDs.

Study Overview

• Status: Terminated
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen

Detailed Description

In the United States, drug overdose deaths and opioid-involved deaths continue to increase, quadrupling since 1999; six out of ten drug overdose deaths involve an opioid. Overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. The amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices has drastically risen, yet there had not been an overall change in the amount of pain that Americans reported. Deaths from prescription opioids-drugs like oxycodone, hydrocodone, and methadone-have more than quadrupled since 1999.

Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to control both postoperative pain and pain associated with some orthopaedic injuries in children and adults with certain orthopaedic injuries. Further, the use of NSAIDs for pain control has been shown to lessen the use of narcotic pain medications, the adverse effects of which are well known. With the current opioid epidemic, more research is needed to determine strategies to reduce opioid use in patients with orthopaedic injuries. Chapman et al. showed that NSAIDs can be used effectively to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. Although distal radius fractures are one of the most common fractures, no studies have examined the effect of NSAIDs on distal radius fracture pain. The purpose of this study is to compare pain and narcotic pain medication use in patients who have had distal radius fractures in patients who use NSAIDs to those who do not.

To the authors' knowledge, there have been no clinical prospective, randomized studies to evaluate the effect that NSAIDs have on patients with distal radius fractures. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Distal radius fracture

Exclusion Criteria:

• Contraindication to NSAID use (ie, cannot tolerate, gastritis, ulcers, chronic kidney disease stage 4 or higher, bleeding disorders/thrombocytopenia)
• Inability to take breakthrough medications
• Regular use of NSAIDs
• Regular use of Narcotics
• Open fracture
• Other orthopaedic injuries (polytrauma)
• Pathologic fracture
• Previous injury to the bone
• Pregnant or plan to become pregnant
• Unable to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acetaminophen; Acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	Drug: Acetaminophen; Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.; Other Names: tylenol
Experimental: NSAID; NSAID administered ibuprofen 400-800 mg, up to three times a day and acetaminophen with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available for breakthrough pain.	Drug: Ibuprofen; NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control; Other Names: Advil; Motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Oxycodone Tablets Used for Breakthrough Pain.	The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.	2 weeks
Intensity of Pain: Visual Analog Scale (VAS)	The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.	2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
Fractures Fully Healed	Radiographic evidence of boney healing of the distal radius. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.	6 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QuickDASH	The QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.	2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity)	The PROMIS UE is scored using a T-score metric, where the mean of the general population is set to 50 with a standard deviation of 10. The minimum score on the PROMIS UE is 0, indicating the lowest level of upper extremity function, while the maximum score is 100, indicating the highest level of upper extremity function. Higher scores represent better upper extremity function.	2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery
Grip Strength	Grip strength refers to the force exerted by your hand muscles when you hold or squeeze something measured in kilograms. It's an essential measure of hand function and overall health. To assess grip strength, you can use a dynamometer-a device that measures the force applied during a handgrip. The test involves squeezing the dynamometer as hard as possible, typically with the elbow bent at a 90-degree angle. Grip strength varies based on factors such as age, sex and hand dominance.	2 Week, 6 Week and 3 Month Post Surgery
Key Pinch Strength	Key pinch strength, also known as lateral pinch strength, measures the force exerted by the hand and fingers when pinching an object between the thumb and the radial side of the index finger. Normal ranges typically fall between 10 to 20 pounds of force (4.54 to 9.07 kgs).	2 weeks, 6 weeks, and 3 months post surgery
Wrist Range of Motion (ROM)	Wrist ROM refers to the ability of the wrist to move in different directions. Normal wrist extension ranges from 70°- 90° resulting in a normal flexion-extension arc of 140-180°. The minimum wrist motion required for daily activities is 60° of extension, 54° of flexion, or approximately a 100° flexion-extension arc. ROM can be varied based on factors such as age, sex, and individual anatomy.	2 weeks, 6 weeks and 3 months post surgery

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Daniel A London, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 2009129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No