What side effects are associated with this type of intervention?

Common treatments for postoperative pain, such as NSAIDs, opioids, and acetaminophen, have various side effects. NSAIDs can cause gastrointestinal issues, renal side effects, and an increased risk of myocardial infarction. Opioids may lead to nausea, vomiting, constipation, respiratory depression, and addiction. Acetaminophen is generally well-tolerated but can cause liver damage at high doses or with prolonged use. These side effects should be considered when managing postoperative pain.

What prior FDA approvals exist?

The FDA has approved several treatments for postoperative pain management, including NSAIDs like ibuprofen and diclofenac, acetaminophen, and multimodal analgesic approaches that may include corticosteroids. High-concentration capsaicin patches have also been used for pain relief. These treatments aim to reduce pain and improve recovery following surgeries such as knee arthroplasty. The trial ATX-101 is investigating a new approach within this context, focusing on effective pain relief post-knee replacement surgery.

What other types of research exist?

Promising alternatives to ATX-101 for postoperative pain relief after knee arthroplasty include: 1) Multimodal analgesia combining opioid and non-opioid analgesics, selective and non-selective anti-inflammatory drugs, which has shown to reduce opioid consumption and side effects. 2) Neuraxial anesthesia, such as spinal or epidural anesthesia, which has been associated with improved long-term survival and reduced short-term complications. 3) Intravenous acetaminophen, which has been effective in reducing opioid consumption post-surgery. 4) Regional anesthesia techniques like femoral nerve blocks, which can provide targeted pain relief and reduce systemic opioid requirements.

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Drug

Bupivacaine + ATX-101 for Knee Surgery Pain (SPARK Trial)

Phase 2

Waitlist Available

Research Sponsored by Allay Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis

Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted)

Must not have

Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine

Has been administered systemic steroids within 14 days prior to surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ATX-101 to see if it can help reduce pain in patients who have had knee replacement surgery. The treatment likely works by reducing inflammation or blocking pain signals. A similar treatment was previously tested for knee pain but was discontinued due to safety concerns.

Who is the study for?

This trial is for adults with knee pain from osteoarthritis or post-traumatic arthritis, scheduled for total knee replacement surgery using a specific anesthesia technique. Participants should be in good to moderate health and not have had recent surgeries, local anesthetics, or certain medical conditions that could affect the study.

What is being tested?

The SPARK study tests the safety and effectiveness of ATX-101 compared to bupivacaine hydrochloride (without epinephrine) for pain relief after knee replacement surgery. It's randomized and double-blind, meaning neither doctors nor patients know who gets which treatment.

What are the potential side effects?

Possible side effects may include typical reactions to local anesthetics like numbness, weakness, backache, headache or dizziness. Since it's a test drug, ATX-101 might also have unknown risks that will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a knee replacement due to arthritis pain.

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I am scheduled for a knee replacement surgery without a drain, using specific anesthesia.

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I am in good to moderate health with or without severe systemic disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't used any experimental drugs or devices in the last 30 days, except for COVID-19 vaccines.

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I have taken steroids within the last 14 days before my surgery.

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I have a weakened immune system or a history of Hepatitis B, HIV, or Hepatitis C.

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I am scheduled for surgery soon.

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I do not have unmanaged mental health or neurological conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 3 trial • 55 Patients • NCT02123134

71%

Injection site pain

71%

Injection site bruising

61%

Injection site swelling

50%

Injection site anaesthesia

29%

Injection site nodule

18%

Injection site oedema

14%

Injection site erythema

14%

Injection site induration

Skin tightness

Dysphonia

Pain in jaw

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

ATX-101 (Deoxycholic Acid) Injection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ATX-101 Dose BExperimental Treatment1 Intervention

ATX-101 Dose B

Group II: ATX-101 Dose AExperimental Treatment1 Intervention

ATX-101 Dose A

Group III: bupivacaine hydrochlorideActive Control1 Intervention

bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ATX-101

2008

Completed Phase 3

~330

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Postoperative pain management often involves NSAIDs, acetaminophen, and local anesthetics. NSAIDs work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing inflammation and pain. Acetaminophen acts centrally to inhibit prostaglandin synthesis, providing analgesic and antipyretic effects without significant anti-inflammatory action. Local anesthetics block sodium channels, preventing nerve signal transmission and thus pain perception. ATX-101, a newer agent under study, may offer targeted pain relief with potentially fewer side effects. Effective pain management is crucial for postoperative patients to enhance recovery, reduce complications, and improve overall outcomes.