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

56 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Opiate Sparing for ACL injury?

Research shows that using fewer opioids after ACL surgery, as part of a multimodal pain management approach, does not increase pain or the need for more prescriptions. This suggests that opioid-sparing methods can effectively manage pain without relying heavily on opioids. ^{1 2 3 4 5}

Is opioid-sparing pain management for ACL injury safe?

Research shows that using techniques like nerve blocks and medications such as liposomal bupivacaine can reduce the need for opioids after ACL surgery, which may help lower the risk of opioid misuse and related side effects. These methods have been used safely in both adults and adolescents undergoing ACL reconstruction. ^{3 4 6 7 8}

How is the Opiate Sparing treatment for ACL injury different from other treatments?

The Opiate Sparing treatment for ACL injury is unique because it focuses on reducing the use of opioids (strong pain-relieving drugs) by using alternative pain management strategies, such as nerve blocks and other non-opioid medications, to effectively manage pain without the risk of opioid dependence. ^{1 3 4 7 9}

What is the purpose of this trial?

This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).

Research Team

Joseph Lamplot, MD

Principal Investigator

Campbell Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

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

Reduced Opioid Prescription After Anterior Cruciate Ligament Reconstruction Does Not Affect Postoperative Pain or Prescription Refills: A Prospective, Surgeon-Blinded, Randomized, Controlled Trial. [2022]

2. United States 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. [2023]

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

Reduced Opioid Use After Surgeon-Administered Genicular Nerve Block for Anterior Cruciate Ligament Reconstruction in Adults and Adolescents. [2022]

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

Variability in Pain Management Practices for Pediatric Anterior Cruciate Ligament Reconstruction. [2023]

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

Pain Management After Outpatient Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Controlled Trials. [2022]

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

Defining the Opioid Requirement in Anterior Cruciate Ligament Reconstruction. [2022]

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

Liposomal Bupivacaine Decreases Post-Operative Opioid Use after Anterior Cruciate Ligament Reconstruction: A Review of Level I Evidence. [2022]

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

Opioid Use in Children and Adolescents After Anterior Cruciate Ligament Repair. [2019]

9. Iran pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of intra-articular morphine after arthroscopic knee surgery in sport injury patients. [2022]