Pain Management for Trauma Recovery

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive NSAIDs and a reduced dosage of opioids for pain management

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 data supports the effectiveness of the drug NSAIDs for pain management in trauma recovery?

Research shows that NSAIDs are effective in managing acute pain after surgery, helping to reduce the need for stronger painkillers like opioids. This suggests they could also be helpful in managing pain after trauma, as they can reduce pain intensity and improve recovery. ^{1 2 3 4 5}

Are NSAIDs generally safe for humans?

NSAIDs (nonsteroidal anti-inflammatory drugs) are commonly used for pain relief but can cause serious side effects like stomach ulcers, heart issues, and kidney problems, especially at high doses or with long-term use. To minimize risks, it's recommended to use the lowest effective dose for the shortest time possible and consider additional protective measures if you have risk factors. ^{6 7 8 9 10}

How do NSAIDs differ from other drugs for trauma pain management?

NSAIDs (nonsteroidal anti-inflammatory drugs) are unique in trauma pain management because they can reduce the need for opioids, which are often associated with side effects like respiratory depression and nausea. Unlike opioids, NSAIDs do not cause these side effects, potentially allowing for faster recovery and earlier discharge from medical care. ^{3 5 11 12 13}

Research Team

Rodolfo Zamora, MD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

NSAIDs in the Treatment of Postoperative Pain. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Change in Pain Score after Administration of Analgesics for Lower Extremity Fracture Pain during Hospitalization. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

[No evidence of malicious effect of NSAID treatment on bone healing]. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Why Pharmacovigilance of Non-steroidal Anti-inflammatory Drugs is Important in India? [2023]

8. Scotland pubmed.ncbi.nlm.nih.gov

Gastroprotection in trauma patients receiving non-steroidal anti-inflammatory drugs. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Are NSAIDs Safe? Assessing the Risk-Benefit Profile of Nonsteroidal Anti-inflammatory Drug Use in Postoperative Pain Management. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

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

12. Italy pubmed.ncbi.nlm.nih.gov

[Systemic analgesia after peripheral block]. [2006]

13. Italy pubmed.ncbi.nlm.nih.gov

Acetaminophen plus codeine compared to ketorolac in polytrauma patients. [2020]