Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00768248
Status:
TERMINATED
Last Update Posted:
2019-08-13
First Post:
2008-10-07
Brief Title:
Naval Medical Center San Diego NMCSD - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No longer enrolling patients not enough enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tubes placed next to the nerves that go to an amputated limb will decrease phantom limb andor stump pain
Detailed Description:
Specific Aim 1 To determine if compared with current standard-of-care treatment the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain
Hypothesis 1 Following upper or lower extremity amputation phantom limb andor stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment as measured on the 11-point numeric rating scale
Specific Aim 2 To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb andor stump pain and cortical reorganization
Hypothesis 2 Following upper or lower extremity amputation with subsequent phantom limb painsensation andor stump pain the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion as measured by MRI
Hypothesis 1 Following upper or lower extremity amputation phantom limb andor stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment as measured on the 11-point numeric rating scale
Specific Aim 2 To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb andor stump pain and cortical reorganization
Hypothesis 2 Following upper or lower extremity amputation with subsequent phantom limb painsensation andor stump pain the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion as measured by MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None