Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study (DoD-PLP-Tx)
Phantom Limb Pain
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring phantom pain, traumatic limb amputation, amputees
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Upper or lower limb traumatic or surgical amputation at least 12 weeks prior to enrollment at or distal to the mid-humerus or hip (femoral head remaining), respectively; and including at least one metacarpal or metatarsal bone, respectively.
- Experiencing at least moderate phantom limb pain (defined as 2 or higher on the numeric rating scale, NRS 0-10), at least three times each week for the previous 8 weeks.
- Accepting of an ambulatory continuous peripheral nerve block for 6 days.
- Willing to avoid changes to their analgesic regimen from 4 weeks prior to and at least 4 weeks following the initial catheter placement (preferably 4 weeks following the second/crossover catheter insertion as well).
- Having a "caretaker" who will transport the subject home following the catheter insertion(s), and remain with the subject for the first night of the infusions.
Exclusion Criteria:
- Known renal insufficiency
- Allergy to study medications
- Pregnancy
- Incarceration
- Inability to communicate with the investigators
- Morbid obesity (BMI greater than 40)
- Comorbidity that results in moderate-to-severe functional limitation (ASA greater than 2)
Possessing any contraindication to ambulatory perineural catheter placement or perineural local anesthetic infusion:
- Current infection
- Immune-compromised status of any etiology
- Uncontrolled anxiety/panic disorder
- Inability to contact investigators during the perineural infusion
Sites / Locations
- Veteran's Affairs Palo Alto Health Care System
- University of California, San Diego, Hillcrest Medical Center
- Walter Reed Army National Medical Center
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ropivacaine 0.5%
Normal saline (salt water) infusion
Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: normal saline.
Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of normal saline placebo fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects assigned this treatment for their initial infusion will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment: ropivacaine 0.5%.