Status:
COMPLETED
Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
United States Department of Defense
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain...
Detailed Description
Background. The combination of increased munitions force, use of improvised explosive devices, and casualty survival rates has resulted in a dramatic increase in the percentage of injured combat veter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01824082
Start Date
December 1 2013
End Date
October 1 2020
Last Update
May 8 2024
Active Locations (4)
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1
Veteran's Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
2
University of California, San Diego, Hillcrest Medical Center
San Diego, California, United States, 92103
3
Walter Reed Army National Medical Center
Bethesda, Maryland, United States, 20889
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195