Lidocaine for Phantom Limb Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Lidocaine, an anesthetic, can ease phantom limb pain when injected near the sciatic nerve of the opposite, intact limb. Participants will receive either a Lidocaine injection or a placebo (a harmless substance with no therapeutic effect) to compare effectiveness. It suits those who had a lower limb amputation over a year ago and continue to experience significant phantom limb pain despite other treatments. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using more than 50 milligrams of opioids per day or have had certain pain treatments in the last 30 days.
What is the safety track record for Lidocaine?
Research has shown that lidocaine, when used for nerve blocks, is generally safe. In one study, participants who received lidocaine experienced significant pain relief, with over 50% reduction in pain. Another study found that lidocaine effectively reduced phantom limb pain over several weeks.
The FDA has also approved lidocaine for other uses, such as numbing tissues, indicating its safety. While side effects like numbness or tingling can occur, they are usually mild and temporary.
Overall, existing studies support lidocaine as a safe option for managing pain.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using lidocaine for phantom limb pain because it offers a different approach from standard treatments like medications or physical therapy. Unlike most treatments that might focus on managing pain through systemic medications, lidocaine is administered as a local injection directly into the back of the residual limb. This method targets the pain more precisely and could potentially provide faster relief by blocking nerve signals in the affected area. Additionally, this approach may minimize systemic side effects, offering a more targeted solution for those suffering from phantom limb pain.
What evidence suggests that Lidocaine might be an effective treatment for phantom limb pain?
Research shows that lidocaine can help reduce certain types of pain. One study found that lidocaine significantly lowered stump pain but did not help with phantom limb pain. Another study found that pain decreased by 33% shortly after using lidocaine, and this reduction improved over time. In this trial, participants in the Lidocaine Group will receive a lidocaine injection in the back of their residual limb to assess its effectiveness on phantom limb pain. Lidocaine has also been used in treatments called peripheral nerve blocks, which have reduced phantom limb pain and improved overall well-being for at least a month. While lidocaine seems promising for pain management, it may be more effective for some types of pain than others.13467
Who Is on the Research Team?
Cole Cheney, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults with phantom limb pain who've had a lower extremity amputation over a year ago and have been in pain for more than 6 months despite trying various treatments. They must be willing to undergo a nerve block and not be on high doses of opioids or other experimental pain drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a lidocaine injection or a placebo injection in the back of their residual limb
Follow-up
Participants are monitored for changes in pain, disability, and functional improvement
What Are the Treatments Tested in This Trial?
Interventions
- Contralateral Limb Block
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor