Pain Management for Trauma Recovery

Not currently recruiting at 1 trial location

Overseen By Salwa Rashid

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Louisville

Disqualifiers: Tibial fractures not intramedullary

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Perioperative period and post-discharge

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two approaches to managing pain after a specific type of leg fracture. Researchers aim to determine if combining non-opioid painkillers (NSAIDs, or non-steroidal anti-inflammatory drugs) with a lower dose of opioids is as effective as using only opioids. They will assess the impact on fracture healing and patient pain levels. This trial targets individuals with a certain lower leg fracture undergoing a specific type of surgery. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that NSAIDs, a type of pain reliever, are generally safe to use after surgery. People who take NSAIDs often experience less pain and require fewer strong painkillers like opioids. One study found that NSAIDs effectively lowered pain levels at various times after surgery. Another study suggested that NSAIDs do not slow down healing post-surgery.

Overall, most people tolerate NSAIDs well. They are widely used in medicine for pain relief, even after surgeries. This information can reassure those concerned about safety when considering joining a trial that uses NSAIDs for pain management. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using NSAIDs for pain management in trauma recovery because they offer a non-opioid alternative for pain relief. Unlike standard opioid treatments, which can be addictive and come with a risk of dependency, NSAIDs help manage pain by reducing inflammation without these risks. This makes NSAIDs an attractive option for effective pain control, particularly in patients who are at risk of opioid-related side effects or addiction.

What evidence suggests that NSAIDs could be an effective treatment for pain management in trauma recovery?

Research has shown that NSAIDs, a type of pain reliever, can effectively manage pain after surgery or injury. In this trial, one group of participants will receive NSAIDs perioperatively and after discharge. These medications help reduce pain and lessen the need for opioids, which are often used for pain relief. In studies, patients who used NSAIDs reported feeling less pain and needed fewer opioids compared to those who did not use NSAIDs. Additionally, NSAIDs did not lead to more complications, making them a safer option for many people. Overall, NSAIDs offer a promising way to manage pain while reducing opioid use. ^{1 3 4 5 6}

Who Is on the Research Team?

Rodolfo Zamora, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 105 who have a specific type of tibia fracture (OTA/AO 42 A, B) and are receiving intramedullary nails as treatment. Those with different types of tibial fractures not treated this way cannot participate.

Inclusion Criteria

I have a specific type of shinbone fracture.

Exclusion Criteria

My broken shinbone was not fixed using a metal rod inside the bone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NSAIDs with reduced opioids or standard opioids for pain control post-operatively

Perioperative period and post-discharge

Follow-up

Participants are monitored for time to union, non-union rate, and post-operative pain using a VAS pain scale

1 year

What Are the Treatments Tested in This Trial?

Interventions

• NSAIDs

Trial Overview

The study compares the effectiveness and pain management between two groups: one taking only opioids, and another using NSAIDs combined with a reduced dose of opioids after surgery for tibia fractures.

How Is the Trial Designed?

Group I: NSAIDs Experimental Treatment 1 Intervention

This arm is given NSAIDs perioperatively and after discharge

Group II: Opioids Active Control 1 Intervention

This arm will be given the standard opioids treatment to control pain perioperatively and at discharge.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

NSAIDs are effective for managing minor to moderate postoperative pain and have advantages over opioids, such as avoiding respiratory depression and nausea, which can lead to faster recovery and earlier hospital discharge.

When used in combination with opioids, NSAIDs can reduce opioid consumption by 20 to 50%, potentially improving pain management while minimizing opioid-related side effects, although they do not necessarily lead to better overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of nonsteroidal antiinflammatory drugs in postoperative pain. Joris, J.[2022]

In India, approximately 1.6 billion NSAID tablets are consumed annually for various conditions, highlighting the widespread use of these medications and the potential for adverse drug reactions (ADRs) due to casual consumption.

Common ADRs associated with NSAIDs include gastrointestinal issues and potential serious effects like renal damage and cardiovascular problems, emphasizing the need for better patient education and pharmacovigilance to ensure safe usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Pharmacovigilance of Non-steroidal Anti-inflammatory Drugs is Important in India? Dash, S., Singh, PA., Bajwa, N., et al.[2023]

NSAIDs are commonly used for pain relief but are associated with a significant rate of side effects, accounting for 9% to 25% of reports to drug surveillance centers worldwide.

To minimize the risk of severe adverse events, it is crucial to assess individual risk factors, use the lowest effective dosage, consider safer alternatives, combine NSAIDs with other analgesics, and inform patients about potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prescription of non-steroidal anti-inflammatory drugs]. Bannwarth, B.[2008]

NSAIDs are effective and safe for managing postoperative pain in most surgical patients, helping to improve patient satisfaction and reduce the need for opioids, which can lead to fewer side effects associated with opioid use.

However, caution is advised when using NSAIDs and COX-2 inhibitors in colorectal surgery due to an increased risk of anastomotic leaks, highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NSAIDs in the Treatment of Postoperative Pain. Gupta, A., Bah, M.[2022]

A review of multiple studies found that nonsteroidal anti-inflammatory drugs (NSAIDs) can effectively reduce the need for opioids in pediatric pain management without compromising pain relief, as they provided similar or better pain scores compared to opioids in most cases.

The use of NSAIDs was associated with similar or lower rates of adverse events compared to opioids, suggesting they are a safer alternative for managing pain in children in emergency and postoperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management in Children: NSAID Use in the Perioperative and Emergency Department Settings. Cooney, MF.[2023]

NSAIDs can be effective for managing postoperative pain after orthopedic surgery, but their use is controversial due to concerns about potential inhibition of bone healing, especially in high-risk patients.

While there is no strong clinical evidence against using NSAIDs in uncomplicated cases, they should be used cautiously, respecting recommended doses and limiting treatment duration to minimize risks of impaired bone healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[No evidence of malicious effect of NSAID treatment on bone healing]. Janum, S., Kristensen, BB.[2012]

Nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective for managing acute postoperative pain and can enhance pain relief when combined with opioids and local anesthetics, leading to reduced narcotic use and improved overall analgesia.

Combining NSAIDs with opioids not only improves pain management but also offers benefits like better respiratory function and reduced nausea, suggesting that NSAIDs may contribute to faster and higher-quality recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of nonsteroidal anti-inflammatory drugs in the management of postoperative pain. Moote, C.[2022]

In a study of 129 adults with lower extremity fractures, hydromorphone 2 mg IV and morphine 4 mg IV were found to provide the largest reductions in pain scores, with 53% and 54% improvement respectively, highlighting their efficacy in acute pain management.

Despite the use of various analgesics, many patients still experienced only minimal pain relief, indicating that current pain management strategies in emergency and inpatient settings may need to be improved to better address moderate to severe pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Pain Score after Administration of Analgesics for Lower Extremity Fracture Pain during Hospitalization. Griffioen, MA., Ziegler, ML., O'Toole, RV., et al.[2020]

In a study of 60 polytrauma patients, the combination of acetaminophen and codeine effectively reduced pain levels, showing comparable efficacy to ketorolac, a commonly used NSAID, without increasing the risk of hemorrhage.

Both treatment groups demonstrated significant pain reduction over 24 hours, suggesting that acetaminophen plus codeine could be a safer alternative for pain management in patients at risk of bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acetaminophen plus codeine compared to ketorolac in polytrauma patients. Franceschi, F., Buccelletti, F., Marsiliani, D., et al.[2020]

NSAIDs are commonly used for various types of pain, but they can cause serious side effects, including gastrointestinal, cardiovascular, and renal complications, which are often dose-dependent.

To reduce the risk of these adverse events, the FDA recommends using the lowest effective dose of NSAIDs for the shortest duration necessary to achieve treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the impact of NSAID-associated adverse events. Fine, M.[2022]

A multimodal approach to acute pain management, combining NSAIDs and opioids, can enhance pain relief while minimizing side effects, which is crucial for postoperative recovery.

Newer NSAIDs, like COX-2 inhibitors, offer effective pain relief with fewer adverse effects, and methods like patient-controlled analgesia (PCA) require specialized management for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systemic analgesia after peripheral block]. Berti, M., Danelli, G., Albertin, A., et al.[2006]

In a study of 644 trauma patients, initial adherence to guidelines for prescribing gastroprotective agents alongside NSAIDs was low at 25.3%, but this significantly improved to 73.1% after an awareness program was implemented.

The proportion of high-risk NSAID users decreased from 75% to 56.5% following the intervention, highlighting the importance of education in reducing the risk of gastrointestinal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastroprotection in trauma patients receiving non-steroidal anti-inflammatory drugs. Chan, JK., Sleat, G., Sharma, S., et al.[2013]

Short-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) for managing acute postoperative pain does not significantly increase the risk of serious adverse effects such as renal dysfunction, bleeding, or gastric complications when used appropriately.

Given the ongoing opioid epidemic, NSAIDs present a safer alternative for postoperative pain management, highlighting the need to consider them as viable options in pain control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are NSAIDs Safe? Assessing the Risk-Benefit Profile of Nonsteroidal Anti-inflammatory Drug Use in Postoperative Pain Management. Chang, RW., Tompkins, DM., Cohn, SM.[2021]

Citations

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Of studies reporting on pain control and reduction of opioids, the use of NSAIDs reduced pain and the need for opioids after traumatic fracture.

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In postoperative critical care adult patients, systemic NSAIDs reduced opioid use and probably reduced pain scores.

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NSAIDs are most effective in managing postoperative pain, healing and recovery when drug administration is limited to the active phase of the circadian rhythm.

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Do NSAIDs Really Interfere with Healing after Surgery?

It analysed another 3 observational studies, of which the largest contributed 93% of cases (anterior cruciate ligament repair); it found overall no difference ...