Nerve Stimulation + Local Anesthetic for Pain After Amputation

Not yet recruiting at 3 trial locations

Overseen By Ksenia (kasimova), MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Opioids, Anticoagulants, Immunosuppressants, others

Disqualifiers: Neuromuscular deficit, Compromised immune, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing pain after below-knee amputations. It combines nerve stimulation with the local anesthetic ropivacaine to determine if this approach is more effective than using the anesthetic alone. The goal is to assess whether adding nerve stimulation can safely reduce pain. Individuals planning a below-knee amputation who do not regularly use opioids may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been using opioids daily in the two weeks before surgery or if you need to restart certain blood-thinning medications within three days after surgery.

What prior data suggests that this combination of nerve stimulation and local anesthetic is safe for pain management after amputation?

Research has shown that peripheral nerve stimulation combined with ropivacaine, a local pain reliever, effectively reduces pain for individuals who have undergone amputations. This combination helps decrease the need for opioid painkillers, which, while strong, can be risky.

Studies have found that individuals receiving this treatment experienced less pain and reported improvement compared to those who did not receive the stimulation. Importantly, these studies suggest the treatment is safe and well-tolerated, with no major safety issues reported.

This treatment is not new; ropivacaine has been used safely for other medical conditions, providing reassurance about its safety when combined with nerve stimulation to manage post-amputation pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for managing pain after amputation because they explore the combination of nerve stimulation with local anesthetics, which is a novel approach. Unlike traditional methods that primarily rely on oral painkillers or local anesthetic blocks alone, the hybrid block treatment offers continuous local anesthetic infusion coupled with peripheral nerve stimulation. This dual approach could provide more effective pain relief by enhancing nerve block efficiency and potentially reducing the need for systemic pain medications. By focusing on these innovative techniques, there is hope for improved pain management and faster recovery for amputees.

What evidence suggests that this trial's treatments could be effective for pain after amputation?

Research has shown that combining peripheral nerve stimulation with a local anesthetic, such as ropivacaine, can reduce pain following an amputation. In this trial, participants in the "Group Hybrid block" arm will receive this combination, which includes continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation. Studies have found that patients using this combination experience less phantom limb pain and pain in the remaining part of the limb. One analysis found that a continuous nerve block, which includes nerve stimulation, reduced pain during the treatment period. Another study found that people using peripheral nerve stimulation experienced less pain and required fewer painkillers. Overall, this evidence suggests that the treatment can effectively manage pain after a lower limb amputation. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients undergoing below-knee amputation who need pain management. It's not clear what specific inclusion or exclusion criteria are, so it's best to contact the study organizers for detailed eligibility requirements.

Inclusion Criteria

I am scheduled for or have had a below-knee amputation.

Exclusion Criteria

Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or another implantable neurostimulator whose stimulus current pathway may overlap

Allergy to study medications or devices (including occlusive dressings, bandages, tape, etc.)

History of substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either continuous local anesthetic infusion or a combination of local anesthetic infusion and peripheral nerve stimulation during the hospital course

72 hours

In-hospital stay

Postoperative Recovery

Participants are monitored for analgesic consumption, quality of recovery, adverse events, and time to ambulation

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness, including assessments of pain and phantom limb pain

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine
• Ropivacaine + nerve stimulator set

Trial Overview The trial compares two pain relief methods after leg amputation: one uses just a local anesthetic (Ropivacaine), and the other combines that anesthetic with nerve stimulation. The goal is to see if adding nerve stimulation helps reduce pain more effectively.

How Is the Trial Designed?

Group I: Group Hybrid block Experimental Treatment 1 Intervention

Continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation.

Group II: Group LA block Active Control 1 Intervention

Continuous local anesthetic infusion through the nerve block catheter.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34314392/

Immediate Effects of a Continuous Peripheral Nerve Block ... This secondary analysis suggests that a continuous peripheral nerve block decreases phantom and residual limb pain during the infusion.

2. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2021-0087

Peripheral nErve Stimulation for the Management of Acute ... Results: The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06719245

Prevention of PostAmputation Pain With Targeted Muscle ... The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a ...

4. painmedicine-casereports.com painmedicine-casereports.com/current/pdf?article=NzEy&journal=51

Use of Peripheral Nerve Stimulation and Perineural ... A random- ized controlled trial by Albright-Trainer et al (9) showed a significant reduction in PLP, residual limb pain , and opioid consumption ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7920494/

Ambulatory continuous peripheral nerve blocks to treat ... We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month. 1.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34761694/

Peripheral nerve stimulation for the management of acute ... Results: The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were ...

7. clinicalpainadvisor.com clinicalpainadvisor.com/news/continuous-peripheral-nerve-block-ropivacaine-phantom-limb-pain/

Continuous Peripheral Nerve Block With Ropivacaine ... According to the PGIC, 53% of ropivacaine recipients compared with 30% of placebo recipients rated their pain as improved at 4 weeks (P =. 008) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11164212/

Primary 3-Month Outcomes of a Double-Blind Randomized ... These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

9. withpower.com withpower.com/trial/phase-amputations-11-2025-1b9d7

Nerve Stimulation + Local Anesthetic for Pain After ... These studies suggest that this approach can reduce pain and improve recovery without significant safety concerns.