Status:
ACTIVE_NOT_RECRUITING
Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative 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
United States Naval Medical Center, San Diego
Conditions:
Lower Extremity Surgical Amputation
Post-amputation Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Subjects will receive 2 perineural catheters: a femoral and sciatic. With a high-frequency linear array ultrasound transducer, the target nerves will be identified in a transverse cross-sectional view...
Eligibility Criteria
Inclusion
- scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone
- continuous peripheral nerve blocks are planned for perioperative analgesia
- willing to have their perineural infusion extended for a total of 7 days
- willing to undergo ambulatory perineural infusion following hospital discharge
Exclusion
- Known hepatic or renal insufficiency
- allergy to any study medication
- pregnancy
- incarceration
- inability to communicate with the investigators
- comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural infusion (e.g., current infection at the catheter insertion site, immune-compromised status of any etiology)
- weight \< 45 kg
- inability to contact the investigators during the perineural infusion, and vice versa (e.g., lack of telephone access)
- investigator opinion that the potential subject is not a good candidate for this particular study
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 18 2026
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03461120
Start Date
March 23 2018
End Date
November 18 2026
Last Update
October 20 2025
Active Locations (8)
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1
University California San Diego
San Diego, California, United States, 92103
2
Naval Medical Center San Diego
San Diego, California, United States, 92134
3
Mass. General Hospital
Boston, Massachusetts, United States, 02114
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115