Trigger Point Injection for Pain After Knee Surgery

Overseen By Dustin L Bennett

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: David Grant U.S. Air Force Medical Center

Must not be taking: Opioids

Disqualifiers: Fibromyalgia, Pregnancy, others

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: 4

Duration: Immediate post-operative period

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, chronic opioid users are excluded, so if you are using opioids daily, you may not be eligible to participate.

What data supports the effectiveness of the treatment Trigger Point Injection for pain after knee surgery?

Research shows that injections of pain-relieving drugs directly into the knee joint, such as corticosteroids and opioids, can help reduce pain and improve movement after knee surgeries. This suggests that similar treatments like Trigger Point Injections might also be effective for managing pain after knee surgery. ^{1 2 3 4 5}

Is Trigger Point Injection generally safe for humans?

Intra-articular injections, which are similar to trigger point injections, have been shown to be generally safe when performed by experienced practitioners. Adverse events are rare when non-opioid analgesics are used appropriately, and regional anesthesia techniques are considered safe. ^{1 3 6 7 8}

How does Trigger Point Injection differ from other treatments for pain after knee surgery?

Trigger Point Injection is unique because it targets specific areas of muscle tightness to relieve pain, unlike other treatments that may involve general pain relief methods like oral medications or injections into the joint itself. This approach can provide targeted relief and potentially reduce the need for systemic medications. ^{1 3 4 9 10}

What is the purpose of this trial?

This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. Given the current state of opioid dependency in the United States there needs to be a more focused attempt at treating post-operative pain without use of opioids. Given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. This study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. This is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). The procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. The sham injection will be completed by pressing the needle against the skin without injecting any fluid. There will be a "blind" between the patient and the needle with both arms of the study. These patients will be followed up on POD1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (MME).

Research Team

Dustin L Bennett

Principal Investigator

David Grant

Eligibility Criteria

This trial is for patients undergoing total knee arthroplasty who may experience post-operative pain potentially linked to myofascial pain syndrome. The study aims to include a small group of 10-15 patients per arm, totaling up to 100 participants.

Inclusion Criteria

DoD beneficiaries

Able to speak, read, and understand English

Willing to bring in their medications to be counted

Exclusion Criteria

Pregnant

Allergy to lidocaine

Chronic opioid users (daily use of prescribed opioids for at least 90 days)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trigger point injections or sham injections immediately following total knee arthroplasty

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for pain and opioid use with follow-up visits on POD1, and during weeks 2 and 6

6 weeks

3 visits (in-person)

Treatment Details

Interventions

• Trigger Point Injection

Trial Overview The study tests if trigger point injections with lidocaine can reduce pain and opioid use after knee surgery compared to sham injections (no fluid injected). Patients won't know which treatment they receive. They'll be assessed on the first day after surgery and at weeks 2 and 6.

Participant Groups

Group I: Experimental group - participants receiving trigger point injections Experimental Treatment 1 Intervention

The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery.

Group II: Sham comparator - Participants not receiving trigger point injections Placebo Group 1 Intervention

The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given.

Who Is Running the Clinical Trial?

David Grant U.S. Air Force Medical Center

Lead Sponsor

Trials

30

Recruited

2,300+

Findings from Research

In a study of 150 patients undergoing arthroscopic ACL reconstruction, intra-articular injection of 5 mg morphine significantly reduced postoperative pain compared to a placebo, leading to lower analgesic requirements in the first 12 hours after surgery.

Morphine was found to be the most effective pain reliever among the opioids tested, while methadone showed the least response, suggesting that morphine is a valuable addition to local anesthetics for pain management in knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison effects of intra-articular injection of different opioids on postoperative pain relieve after arthroscopic anterior cruciate ligament reconstruction: A randomized clinical trial study. Arti, H., Mehdinasab, SA.[2022]

In a study of 63 patients undergoing knee arthroscopy, the combination of ropivacaine, morphine, and ketorolac provided significantly better pain relief compared to bupivacaine or ropivacaine alone, especially at 8 and 24 hours post-surgery.

The combination treatment not only reduced the need for additional pain medication but also improved patients' daily activities and satisfaction without increasing side effects, indicating a safer and more effective pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. Ng, HP., Nordström, U., Axelsson, K., et al.[2022]

Multimodal analgesia that minimizes opioid use after surgery can reduce postoperative pain and the risk of complications, highlighting the importance of using non-opioid analgesics like NSAIDs, gabapentinoids, and regional anesthesia techniques.

Non-opioid analgesics generally have a low risk of adverse events when used appropriately, although certain medications like α-2 agonists and gabapentinoids may have specific risks, emphasizing the need for standardized protocols to enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. Jin, Z., Lee, C., Zhang, K., et al.[2021]

In a study of 60 patients who underwent total knee arthroplasty (TKA), those receiving perineural injection therapy (PIT) showed significantly better pain management and functional outcomes compared to those receiving standard postoperative care, as measured by the WOMAC and VAS scores.

PIT demonstrated high clinical efficacy with 93.5% of patients reporting excellent or good outcomes, while also being a cost-effective and safe treatment option with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. Güzel, İ., Gül, D., Akpancar, S., et al.[2021]

References

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

Risk of Periprosthetic Infection Following Intra-Articular Corticosteroid Injections After Total Knee Arthroplasty. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of intra-articular meperidine and bupivacaine 0.5% on postoperative pain of arthroscopic knee surgery; a randomized double blind clinical trial. [2020]

3. India pubmed.ncbi.nlm.nih.gov

The comparison effects of intra-articular injection of different opioids on postoperative pain relieve after arthroscopic anterior cruciate ligament reconstruction: A randomized clinical trial study. [2022]

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

Efficacy of Additional Corticosteroid in a Multimodal Cocktail for Postoperative Analgesia Following Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of intra-articular bupivacaine, ropivacaine, or a combination of ropivacaine, morphine, and ketorolac on postoperative pain relief after ambulatory arthroscopic knee surgery: a randomized double-blind study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of intra-articular analgesics after knee arthroscopy: a Bayesian network meta-analysis protocol. [2021]

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

Effect of a perioperative intra-articular injection on pain control and early range of motion following bilateral TKA. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety of treatment options available for postoperative pain. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The impact of including corticosteroid in a periarticular injection for pain control after total knee arthroplasty: a double-blind randomised controlled trial. [2022]

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

Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. [2021]