203 Participants Needed

Continuous Peripheral Nerve Blocks for Phantom Limb Pain

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

When a limb is amputated, pain perceived in the part of the body that no longer exists often develops, called "phantom limb" pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that are associated with persistent pain. The negative feedback-loop between the injured limb and the brain can be stopped by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain. A "continuous peripheral nerve block" (CPNB) is a technique providing pain relief that involves inserting a tiny tube-smaller than a piece of spaghetti-through the skin and next to the target nerve. Local anesthetic is then introduced through the tiny tube, which bathes the nerve in the numbing medicine. This provides a multiple-day block that provides opioid-free pain control with no systemic side effects, and may prevent the destructive feedback loop that results in phantom limb pain following an amputation. We propose a multicenter, randomized, triple-masked (investigators, subjects, statisticians), placebo-controlled, parallel arm, human-subjects clinical trial to determine if a prolonged, high-concentration (dense), perioperative CPNB improves post-amputation physical and emotional functioning while decreasing opioid consumption, primarily by preventing chronic phantom limb pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for phantom limb pain?

Research shows that a 6-day continuous peripheral nerve block can reduce phantom limb pain and improve physical and emotional well-being for at least one month after treatment. In a study, patients who received this treatment reported lower pain levels compared to those who received a placebo.12345

Is continuous peripheral nerve block generally safe for humans?

Continuous peripheral nerve blocks (CPNBs) have been used in various medical settings, including orthopedic surgeries and battlefield anesthesia, with studies indicating they can be safe and effective for pain management. They may have fewer side effects compared to other pain relief methods, but like any medical procedure, they can have complications, so it's important to discuss potential risks with your healthcare provider.16789

How does the continuous peripheral nerve block treatment for phantom limb pain differ from other treatments?

Continuous peripheral nerve blocks are unique because they involve a 6-day infusion of a local anesthetic directly around the nerves, which helps disrupt the nerve pathways thought to cause phantom limb pain. This method is different from other treatments as it directly targets the nerves and has shown to reduce pain and improve physical and emotional function for at least a month.123410

Research Team

Brian M. Ilfeld, MD - Anesthesiology ...

Brian Ilfeld, MD

Principal Investigator

University California San Diego

Eligibility Criteria

This trial is for individuals scheduled for unilateral lower limb amputation who are willing to have a nerve block infusion for 7 days, including after hospital discharge. They must not have liver or kidney issues, allergies to study meds, be pregnant or incarcerated, and must be able to communicate with researchers.

Inclusion Criteria

I am scheduled for a leg amputation below the hip that includes part of my foot.
I am willing to undergo a 7-day perineural infusion treatment.
I am scheduled for pain relief via nerve blocks around surgery time.
See 1 more

Exclusion Criteria

I have liver or kidney problems.
Allergy to any study medication
Pregnancy
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continuous peripheral nerve blocks (CPNB) with either bupivacaine or ropivacaine for pain management post-amputation

7 days
Daily monitoring via telephone

Follow-up

Participants are monitored for mobility, pain, and opioid consumption at various intervals post-surgery

12 months
Postoperative days 1, 2, 8; Months 1, 3, 6, 9, and 12

Treatment Details

Interventions

  • Control continuous peripheral nerve blocks
  • Experimental continuous peripheral nerve blocks
Trial Overview The study tests if using a high-concentration continuous peripheral nerve block (CPNB) around the time of leg amputation can improve recovery by reducing phantom limb pain and opioid use. Participants will either receive the experimental CPNB or a control version in this randomized, triple-masked trial.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Bupivacaine 0.3% \[or ropivacaine 0.5%\] infusion for 7 days via femoral and sciatic perineural catheters
Group II: ControlExperimental Treatment1 Intervention
Bupivacaine 0.1% \[or ropivacaine 0.2%\] infusion for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Wake Forest University Health Sciences

Collaborator

Trials
1,432
Recruited
2,506,000+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Boston VA

Collaborator

Trials
1
Recruited
200+

Mass. General Hospital

Collaborator

Trials
1
Recruited
200+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

United States Naval Medical Center, San Diego

Collaborator

Trials
110
Recruited
24,200+

Walter Reed National Military Medical Center

Collaborator

Trials
149
Recruited
33,800+

References

Patient-centered results from a multicenter study of continuous peripheral nerve blocks and postamputation phantom and residual limb pain: secondary outcomes from a randomized, clinical trial. [2023]
Immediate Effects of a Continuous Peripheral Nerve Block on Postamputation Phantom and Residual Limb Pain: Secondary Outcomes From a Multicenter Randomized Controlled Clinical Trial. [2023]
Ambulatory continuous peripheral nerve blocks to treat postamputation phantom limb pain: a multicenter, randomized, quadruple-masked, placebo-controlled clinical trial. [2023]
An unusual case of painful phantom-limb sensations during regional anesthesia. [2019]
Continuous regional analgesia by intraneural block: effect on postoperative opioid requirements and phantom limb pain following amputation. [2022]
Complications and adverse effects associated with continuous peripheral nerve blocks in orthopedic patients. [2007]
Continuous peripheral nerve block for battlefield anesthesia and evacuation. [2022]
Continuous peripheral nerve block for in-patients with lower limb ischemic pain. [2022]
Outcomes of Ambulatory Upper Extremity Surgery Patients Discharged Home with Perineural Catheters from a Veterans Health Administration Medical Center. [2020]
Phantom limb pain relief by contralateral myofascial injection with local anaesthetic in a placebo-controlled study: preliminary results. [2022]
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