Opioid-Sparing Pain Management for ACL Injury

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Campbell Clinic

Must not be taking: SSRIs, SNRIs, GLP-1 agonists

Disqualifiers: Substance abuse, Chronic pain, Diabetes, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a pain management plan aimed at reducing opioid use after ACL surgery. Researchers aim to determine if a combination of medications can control pain as effectively as traditional opioid-based treatments, but with fewer side effects and risks. Participants will join either a group receiving a mix of non-opioid and limited opioid medications or a group following a more typical opioid-based regimen. Those scheduled for ACL surgery who have not used opioids before might be suitable candidates. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking pain management approach.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, like selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, and glucagon-like peptide 1 agonists, before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a combination of different medications, known as multimodal opioid-sparing regimens, can effectively manage post-surgery pain. This approach significantly reduces the need for opioids, helping to avoid problems related to opioid use.

The opioid-sparing treatment includes medications like Medrol, Diclofenac, Tylenol, Gabapentin, and Methocarbamol. These drugs are commonly used in other treatments and are generally considered safe. Most patients tolerate them well, with few reports of serious side effects. Common side effects might be mild, such as nausea or constipation, and can be managed.

Overall, research supports the safety and effectiveness of the opioid-sparing regimen for managing pain after ACL surgery. However, as with any treatment, individual experiences may vary, so discussing any concerns with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the opioid-sparing approach for ACL injury pain management because it aims to minimize the use of opioids, which are commonly used but carry risks of addiction and side effects. Unlike traditional opioid-based regimens, this treatment uses a combination of medications like Medrol Dosepak, diclofenac, gabapentin, methocarbamol, and limited opioids only for severe pain, reducing the dependency on stronger narcotics. This approach not only targets pain through multiple pathways but also emphasizes safety and recovery through adjunct therapies like physical therapy, which is expected to start shortly after surgery. By potentially reducing opioid usage, this regimen offers a promising alternative that could improve patient outcomes and recovery times.

What evidence suggests that this trial's treatments could be effective for ACL injury?

This trial will compare two approaches to pain management after ACL surgery: an opioid-sparing regimen and an opioid-based regimen. Research has shown that using fewer strong painkillers after ACL surgery can effectively manage pain. Instead, other types of pain relief, such as NSAIDs (nonsteroidal anti-inflammatory drugs), work well. One study found that a plan using fewer opioids significantly reduced their use after surgery. This method can help patients recover faster and with fewer side effects. Overall, evidence supports that using fewer opioids is an effective way to manage pain after surgery. ^{1 3 5 6 7}

Who Is on the Research Team?

Joseph Lamplot, MD

Principal Investigator

Campbell Clinic

Are You a Good Fit for This Trial?

This trial is for individuals undergoing Anterior Cruciate Ligament Reconstruction (ACL-R) who are interested in managing post-operative pain with a potential reduction in opioid use. Specific eligibility criteria details were not provided.

Inclusion Criteria

I weigh at least 90lbs.

Willing and able to provide written informed consent

Willing and able to cooperate with postoperative therapy

Exclusion Criteria

Substance abuse disorder (illicit drug abuse, alcoholism, etc)

I am taking pain medication for injuries or surgeries.

Pre-injury opioid consumption

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an opiate sparing or opiate based analgesic regimen post-ACL reconstruction surgery

2 weeks

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2-week, 6-week, and 12-week follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Opiate Sparing

Trial Overview The study is testing two pain management approaches after ACL surgery: one that tries to minimize the use of opioids (opiate sparing), and another that uses standard opioid-based methods. It's a randomized trial, meaning participants are randomly assigned to one of these groups.

How Is the Trial Designed?

Group I: Opiate Sparing Experimental Treatment 1 Intervention

Discharge medications: 1. Medrol Dosepak, take per package instructions from postoperative day 1 to postoperative day 6. 2. Diclofenac 75 milligram (mg) twice per day from postoperative day 7 to postoperative day 14. 3. Tylenol 1000 mg three times per day from postoperative day 1 to postoperative day 14. 4. Gabapentin 100 mg three times per day from postoperative day 1 to postoperative day 14. 5. Methocarbamol (Robaxin) 750mg twice per day from postoperative day 1 to postoperative day 14. 6. Promethazine 25 mg every 8 hours as needed for nausea. 7. Aspirin 81 once per day from postoperative day 1 to postoperative day 30. 8. Senokot-S (Sennosides and Docusate) as needed for constipation. 9. 10 tablets of Tramadol 50mg as needed for moderate breakthrough pain only. 10. 5 tablets of oxycodone 5mg as needed for severe breakthrough pain only. 11. Supervised physical therapy to start within postoperative day 2 and postoperative day 7.

Group II: Opiate Based Active Control 1 Intervention

Discharge medications: 1. Diclofenac 75 milligram (mg) twice per day from postoperative day 1 to postoperative day 14. 2. Tylenol 1000 mg three times per day from postoperative day 1 to postoperative day 14. 3. Gabapentin 100 mg three times per day from postoperative day 1 to postoperative day 14. 4. Methocarbamol (Robaxin) 750mg twice per day from postoperative day 1 to postoperative day 14. 5. Promethazine 25 mg every 8 hours as needed for nausea. 6. Aspirin 81 once per day from postoperative day 1 to postoperative day 30. 7. Senokot-S (Sennosides and Docusate) as needed for constipation. 8. 10 tablets of Tramadol 50mg as needed for moderate breakthrough pain only. 9. 5 tablets of oxycodone 5mg as needed for severe breakthrough pain only. 10. Supervised physical therapy to start within postoperative day 2 and postoperative day 7.

Who Is Running the Clinical Trial?

Campbell Clinic

Lead Sponsor

Trials

15

Recruited

2,100+

Published Research Related to This Trial

In a study involving 40 athletes undergoing arthroscopic knee surgery, the use of 15 mg of intra-articular morphine significantly improved pain relief and extended the duration of analgesia compared to lower doses and saline.

No drowsiness or significant side effects were reported in any of the groups within the first 24 hours, indicating that 15 mg of morphine is a safe option for post-surgery pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of intra-articular morphine after arthroscopic knee surgery in sport injury patients. Yari, M., Saeb, M., Golfam, P., et al.[2022]

Regional nerve blocks and intra-articular injections are effective methods for managing pain after ACL reconstruction, with indwelling femoral catheters providing superior analgesia compared to single-injection nerve blocks, although they may lead to complications like motor deficits.

Early weightbearing and the use of medications like gabapentin and ibuprofen can significantly reduce opioid consumption and pain levels, highlighting the importance of a multimodal approach to pain management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management After Outpatient Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Controlled Trials. Secrist, ES., Freedman, KB., Ciccotti, MG., et al.[2022]

In a study of 50 patients undergoing ACL surgery, it was found that prescribing a median of 15 oxycodone 5-mg pills resulted in only 34% of the prescribed opioids being consumed, indicating that current opioid prescription guidelines may be excessive.

Despite the lower opioid prescription, patients reported low pain levels (mean score of 2.8 out of 10) and high satisfaction with pain management (4.1 out of 5), suggesting effective pain control can be achieved with fewer opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Requirement After Anterior Cruciate Ligament Surgery: Opioid Use After Anterior Cruciate Ligament Surgery Is Low With a Multimodal Approach, and Fifteen Oxycodone 5-mg Tablets Are Sufficient. Liddy, N., Kamdar, PM., Quintana, JO., et al.[2023]

Citations

1. withpower.com withpower.com/trial/opioid-sparing-pain-management-for-acl-injury-966dc

Opioid-Sparing Pain Management for ACL Injury This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and ...

2. ctv.veeva.com ctv.veeva.com/study/acl-r-opioid-sparing-study

ACL-R Opioid Sparing Study - ClinicalTrials.Veeva Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11935147/

Biochemical strategies for opioid-sparing pain management in ... It directly impactsdirectly impacts patient outcomes, recovery time, and surgical success. Opioids have been the top choice for pain management.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2796947

Effect of Opioid-Sparing Protocol vs Standard Prescribing ... A multimodal opioid-sparing postoperative pain protocol, compared with standard opioid prescribing, significantly reduced postoperative opioid consumption over ...

5. rapm.bmj.com rapm.bmj.com/content/50/6/455

Multisite prospective study of perioperative pain ... We found substantial variability in the use of blocks to manage post-ACLR pain in children, with a small percentage experiencing long-term pain and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06561035?term=aspirin%20AND%20methocarbamol&rank=3

NCT06561035 | ACL-R Opioid Sparing Study A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9533185/

Effect of a Postoperative Multimodal Opioid-Sparing Protocol ... A multimodal opioid-sparing postoperative pain protocol, compared with standard opioid prescribing, significantly reduced postoperative opioid consumption over ...