Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01824082
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2013-03-30
Brief Title:
Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks A Department of Defense Funded Multicenter Study
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Treating Intractable Post-Amputation Phantom Limb Pain With Ambulatory Continuous Peripheral Nerve Blocks
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DoD-PLP-Tx
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 within the part of the limb that remains intact Unfortunately phantom pain resolves in only 16 of people with the rest experiencing this pain for the remainder of the lives There is currently no reliable treatment for phantom limb pain
The exact reason that phantom limb pain occurs is unclear but when a nerve is cut-as happens with a traumatic amputation-changes occur in the brain and spinal cord that actually worsen with increasing phantom pain These abnormal changes may often be corrected by putting local anesthetic-termed a peripheral nerve block-on the injured nerve keeping any bad signals from reaching the brain with resolution of the phantom limb pain However when the nerve block ends after a few hours the phantom pain returns But this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation may be dependent upon the bad signals being sent from the injured nerves suggesting that a very long peripheral nerve block-lasting many days rather than hours-may permanently reverse the abnormal changes in the brain and provide lasting relief from phantom pain
Until recently extending a peripheral nerve block beyond 16 hours was unrealistic However a treatment option called a continuous peripheral nerve block is now available This technique involves the placement of a tiny tube-smaller than a piece of spaghetti-through the skin and next to the nerves supplying the amputated limb The tiny tube may be placed with minimal discomfort in about 15 minutes Numbing medicine called local anesthetic is then infused through the tube blocking any signals that the injured nerve sends to the spinal cord and brain Using a small portable infusion pump this prolonged nerve block may be provided in individuals own homes
The ultimate objective of the proposed research study is to determine if a 6-day continuous peripheral nerve block provided at home is an effective treatment for persistent phantom limb pain following a traumatic limb amputation The primary hypothesis what the researchers predict is that phantom limb pain intensity will be significantly decreased 4 weeks following treatment with a 6-day continuous peripheral nerve block
The exact reason that phantom limb pain occurs is unclear but when a nerve is cut-as happens with a traumatic amputation-changes occur in the brain and spinal cord that actually worsen with increasing phantom pain These abnormal changes may often be corrected by putting local anesthetic-termed a peripheral nerve block-on the injured nerve keeping any bad signals from reaching the brain with resolution of the phantom limb pain However when the nerve block ends after a few hours the phantom pain returns But this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation may be dependent upon the bad signals being sent from the injured nerves suggesting that a very long peripheral nerve block-lasting many days rather than hours-may permanently reverse the abnormal changes in the brain and provide lasting relief from phantom pain
Until recently extending a peripheral nerve block beyond 16 hours was unrealistic However a treatment option called a continuous peripheral nerve block is now available This technique involves the placement of a tiny tube-smaller than a piece of spaghetti-through the skin and next to the nerves supplying the amputated limb The tiny tube may be placed with minimal discomfort in about 15 minutes Numbing medicine called local anesthetic is then infused through the tube blocking any signals that the injured nerve sends to the spinal cord and brain Using a small portable infusion pump this prolonged nerve block may be provided in individuals own homes
The ultimate objective of the proposed research study is to determine if a 6-day continuous peripheral nerve block provided at home is an effective treatment for persistent phantom limb pain following a traumatic limb amputation The primary hypothesis what the researchers predict is that phantom limb pain intensity will be significantly decreased 4 weeks following treatment with a 6-day continuous peripheral nerve block
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 veterans living with a traumatic amputation Of American Veteran amputees 35-98 develop chronic intractable pain perceived as being from the missing limb a phenomenon termed phantom limb pain This pain resolves in only 16 of afflicted individuals and there is currently no reliable treatment The etiology of phantom pain remains unclear but evidence suggests that severing a nerve provokes changes in the spinal cord thalamus and cerebral cortex When neural input from an amputated limb is blocked with local anesthetic a peripheral nerve block cortical abnormalities and phantom pain frequently resolve However when the single-injection nerve block resolves after a few hours the phantom pain returns These findings demonstrate that cortical abnormalities and phantom pain may be maintained from abnormal peripheral input suggesting that a peripheral nerve block of extended duration-lasting many days rather than hours-may permanently reorganize cortical pain mapping thus providing lasting relief from phantom pain A continuous peripheral nerve block CPNB involves the percutaneous insertion of a catheter directly adjacent to the peripheral nerves supplying an affected limb Local anesthetic infused via the catheters induces a completely insensate extremity for as long as desired without any systemic side effects Additionally CPNB may be provided on an ambulatory basis using a small portable pump to infuse the local anesthetic
Objective To determine if ambulatory CPNB is an effective treatment for intractable phantom limb pain following a traumatic limb amputation Previously-published small uncontrolled series describe patients immediately following surgical amputation whose phantom limb pain dramatically decreased or completely resolved with CPNB We have data from a randomized double-masked placebo-controlled crossover pilot study suggesting great promise treating intractable phantom limb pain with ambulatory CPNB participants n3 experienced no change in their phantom pain following a 6-day infusion of normal saline however with a 6-day CPNB of potent local anesthetic administered 4 months later subjects n2 one patient returned to duty before crossover infusion experienced complete resolution of their phantom limb pain Within the 12-week follow-up period one subject experienced no phantom pain recurrence and the other subject reported mild pain occurring once each week of just a small fraction of his original pain
Specific Aims The primary hypothesis is that phantom limb pain intensity will be significantly decreased 4 weeks following an ambulatory CPNB as measured by the Numeric Rating Scale of the Brief Pain Inventory
Study Design We propose a multicenter randomized double-masked placebo-controlled simultaneous parallel and crossover human-subjects clinical trial We will include subjects with an existing upper or lower amputation who experience phantom limb pain at least daily for the previous 4 weeks Catheter sites will be determined by amputation location Subjects will be randomized to receive one of two study solutions in a double-masked manner either a local anesthetic ropivacaine 05 or placebo normal saline Catheters will be removed after 6 days of at-home infusion Although not required each subject has the option to return for the alternative treatment four weeks later crossover infusion The primary endpoint will be the difference in average phantom pain intensity at baseline and 4 weeks following the initial infusion as measured with the Numeric Rating Scale between treatment groups for the initial infusion Major secondary endpoints will involve intra- and inter-subject comparisons of additional measures of pain and health-related quality-of-life
Clinical Impact From 2001-2006 over 70 of all US military casualties endured a major limb injury with an amputation rate of 28 within Operation Enduring Freedom alone Previous conflicts have left tens-of-thousands of United States Armed Forces Veterans with missing limbs CPNB are now relatively ubiquitous within the United States but applied nearly exclusively to provide acute post-injurysurgical analgesia If the proposed study demonstrates that ambulatory CPNB is a reliable treatment for intractable phantom limb pain the resulting impact in treating the consequences of traumatic amputation will be immediate and profound as healthcare providers within the United States Armed Forces and Veterans Affairs Medical Centers already have expertise placing and managing perineural catheters Currently CPNB is provided exclusively in the acute setting-to treat pain immediately following a battlefield injury or surgery-and not chronic intractable phantom limb pain However because there is little technical difference in providing CPNB for acute versus chronic pain the thousands of US Veterans and active duty personnel suffering from intractable phantom pain could be treated relatively easily rapidly and with negligible additional costs
Objective To determine if ambulatory CPNB is an effective treatment for intractable phantom limb pain following a traumatic limb amputation Previously-published small uncontrolled series describe patients immediately following surgical amputation whose phantom limb pain dramatically decreased or completely resolved with CPNB We have data from a randomized double-masked placebo-controlled crossover pilot study suggesting great promise treating intractable phantom limb pain with ambulatory CPNB participants n3 experienced no change in their phantom pain following a 6-day infusion of normal saline however with a 6-day CPNB of potent local anesthetic administered 4 months later subjects n2 one patient returned to duty before crossover infusion experienced complete resolution of their phantom limb pain Within the 12-week follow-up period one subject experienced no phantom pain recurrence and the other subject reported mild pain occurring once each week of just a small fraction of his original pain
Specific Aims The primary hypothesis is that phantom limb pain intensity will be significantly decreased 4 weeks following an ambulatory CPNB as measured by the Numeric Rating Scale of the Brief Pain Inventory
Study Design We propose a multicenter randomized double-masked placebo-controlled simultaneous parallel and crossover human-subjects clinical trial We will include subjects with an existing upper or lower amputation who experience phantom limb pain at least daily for the previous 4 weeks Catheter sites will be determined by amputation location Subjects will be randomized to receive one of two study solutions in a double-masked manner either a local anesthetic ropivacaine 05 or placebo normal saline Catheters will be removed after 6 days of at-home infusion Although not required each subject has the option to return for the alternative treatment four weeks later crossover infusion The primary endpoint will be the difference in average phantom pain intensity at baseline and 4 weeks following the initial infusion as measured with the Numeric Rating Scale between treatment groups for the initial infusion Major secondary endpoints will involve intra- and inter-subject comparisons of additional measures of pain and health-related quality-of-life
Clinical Impact From 2001-2006 over 70 of all US military casualties endured a major limb injury with an amputation rate of 28 within Operation Enduring Freedom alone Previous conflicts have left tens-of-thousands of United States Armed Forces Veterans with missing limbs CPNB are now relatively ubiquitous within the United States but applied nearly exclusively to provide acute post-injurysurgical analgesia If the proposed study demonstrates that ambulatory CPNB is a reliable treatment for intractable phantom limb pain the resulting impact in treating the consequences of traumatic amputation will be immediate and profound as healthcare providers within the United States Armed Forces and Veterans Affairs Medical Centers already have expertise placing and managing perineural catheters Currently CPNB is provided exclusively in the acute setting-to treat pain immediately following a battlefield injury or surgery-and not chronic intractable phantom limb pain However because there is little technical difference in providing CPNB for acute versus chronic pain the thousands of US Veterans and active duty personnel suffering from intractable phantom pain could be treated relatively easily rapidly and with negligible additional costs
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