Aminocaproic acid for Opioid Pain Medication

Phase-Based Estimates
3
Effectiveness
3
Safety
NYU Langone Health, New York, NY
Aminocaproic acid - Drug
Eligibility
18+
All Sexes
Eligible conditions
Opioid Pain Medication

Study Summary

This study is evaluating whether a combination of antifibrinolytics and local anesthetics may help reduce pain and the need for narcotics following hand surgery.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Aminocaproic acid will improve 1 primary outcome and 1 secondary outcome in patients with Opioid Pain Medication. Measurement will happen over the course of Day1 of Surgery until post operative day 14.

Day 14
Change in Postoperative Pain control
Change in the amount of opioid pain medication required postoperatively

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

No Control Group
Topical lidocaine and bupivacaine alone

This trial requires 40 total participants across 4 different treatment groups

This trial involves 4 different treatments. Aminocaproic Acid is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Topical lidocaine and bupivacaine aloneIn this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
Topical lidocaine and bupivacaine with thrombinIn this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
Topical lidocaine and bupivacaine with thrombin and tranexamic acidIn this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
Topical lidocaine and bupivacaine with thrombin and aminocaproic acid;In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day1 of surgery until post operative day 14
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day1 of surgery until post operative day 14 for reporting.

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 or older
Any patient undergoing elective hand surgery

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for opioid pain medication?

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Most often, treatments for opioid pain relief are not prescribed by the healthcare provider or the patient, although it's possible that they take place at their home. Some patients may be prescribed opioids at home.\n

Unverified Answer

What is opioid pain medication?

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It is important that all physicians and patients adequately understand what opioid medications are to be used for which conditions and what safety precautions are necessary when opioid medications are being prescribed to patients.

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How many people get opioid pain medication a year in the United States?

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About 18% of American Americans take pain medication every day, and over 14% take opioid pain medication every day. While only 5% of US adults have had a period of non-medical opioid use, about 7% of US adults have had one or more major opioid prescription drug interactions, with a quarter of those taking opioids. Only 10% of opioid prescribed patients received information regarding drug interactions. Therefore, over 90% of prescription opioid use in real-world practice may be associated with potentially lethal opioid drug interactions.

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Can opioid pain medication be cured?

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Pain is common/endorphine use is common. A very large proportion of users experience a long-lasting reduction of opioid use and a cure. Clinically relevant benefits of opioid medication are rare and more likely to be side effects and addiction than good, perhaps life-long, reductions in pain. Results from a recent paper supports the use of a cure-focused approach to pain management.

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What are the signs of opioid pain medication?

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Many different signs are associated with opioids. Most of the signs are vague, while others are more specific. Common symptoms include dizziness or lightheadedness, shortness of breath, and constipation or nausea/vomiting. An increased heart rate, sweating, drowsiness and decreased alertness may be observed. There may also be increased pain when the subject experiences pain with or without opioid use. Severe withdrawal is associated with a severe flu-like reaction. Alcohol use is often combined with opioid use, making signs of alcohol use in combination with opioid use more subtle. Opioid-related signs and symptoms are often overlooked or mistaken for other conditions.

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What causes opioid pain medication?

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It appears that factors such as family history, sex and genetics, health and social factors, and psychosocial stress may contribute to which individuals use opioid medications. Despite this complex relationships the use of opioids to treat pain in the elderly is still a major issue.

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How does aminocaproic acid work?

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Aminocaproic acid seems to induce an antiinflammatory response, thereby lowering blood-proteins levels and relieving pain. However, due to the low number of randomized double-blind studies with appropriate design, little can be said about the absolute indications, effects, and side-effects of this drug compared with other analgesics. The authors' opinion is that the absolute data need to be pooled from random double-blind trials and compared with placebo for further evaluation.

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Is aminocaproic acid typically used in combination with any other treatments?

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ACP is prescribed as a first-line treatment for a broad spectrum of dermatologic conditions, and is usually combined with an antipruritic. Although this study identified several small trials showing the safety and effectiveness of ACP with standard analgesic treatment, as of February 2013, no placebo-controlled trials that studied the combination of ACP and a standard analgesic had been published, and we could not identify any clinical trials specifically investigating the use of ACP with analgesics for treatment of HNP. In a recent study, findings could have been different had ACP been used alone. The study was largely based on individual patient cases and small trial designs, some used to investigate the mechanism of action of ACP alone.

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What is the primary cause of opioid pain medication?

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Recent findings found that many patients had been prescribed opioids for reasons other than their primary complaint of pain. This finding would suggest that there is a group of patients who are misdiagnosed as having a primary complaint of pain and receive treatment with opioids based on that misdiagnosis. The use of a pain specialist as part of a comprehensive medical panel should assist physicians in assessing and managing the patients' pain.

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Does opioid pain medication run in families?

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Significant heritability was noted for pain scores, tolerance to morphine, physical dependence and opioid-induced hyperalgesia (OIHA). Data from a recent study also suggest that the heritability of OIHA is largely unrelated to that of baseline pain scores and morphine tolerance and that OIHA may be a functional somatic symptom, possibly due to dysregulation of brain endorphin systems.

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Is aminocaproic acid safe for people?

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ACPA is an antidote for most agents (except for sodium fluoroacetate, a medication of veterinary origin). However, the dose-toxicity information available is too poor to allow safe use as an antidote. The only reliable data show that intravenous injection of ACPA is not teratogenic, that is, it does not cause birth defects.

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What does aminocaproic acid usually treat?

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Aminocaproic acid is used in a number of conditions, and it's safety profile has been well studied. It has been shown to decrease pain in many chronic conditions and also for acute pain. It is sometimes used in patients who have a high dose of pain medication in their treatment plan (such as opioids), as a short-term add on therapy. Aminocaproic acid is also used during dental procedures to control bleeding from nerves. There are a number of reports of patients having adverse responses to aminocaproic acid resulting in the death of the patient including two of the authors (a dentist and a dentist assistant).

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