Amputation, Phantom Limb, Stump Pain
Conditions
Keywords
pain, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, NMCSD, Post-Amputation Phantom Limb or Stump Pain
Brief summary
The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or 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 and/or 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 and/or stump pain and cortical reorganization. Hypothesis 2: Following upper or lower extremity amputation with subsequent phantom limb pain/sensation and/or 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).
Interventions
ropivacaine 0.4%; the basal rate will be set at 7 mL/h
DRUGnormal saline (placebo)
the basal rate will be set at 7 mL/h
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* previous upper or lower limb amputation including at least one metacarpal or metatarsal bone, respectively * age 18 years or older * phantom limb and/or stump pain described as at least a 2 on the NRS for the previous week \[and pain occurring on a weekly basis over the previous month\] * willing to have an ambulatory perineural infusion for 6 days * willing to avoid additional new analgesic interventions from 4 weeks prior to at least 4 weeks following catheter placement, and preferably to 6 months following catheter placement * the availability of a caretaker who will transport the subject home following the procedure and remain with the subject for the first night of the infusion
Exclusion criteria
* known hepatic or renal insufficiency * allergy to the study medications * possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Physical Functioning · Brief Pain Inventory | pre-intervention, then days 1, 3, 8, 28, 84, and 365 |
| Emotional Functioning · Beck Depression Inventory | pre-intervention; and then day 28 and 365 post-intervention |
| Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure | pre-intervention; and then 8 and 28 days post-intervention |
| Pain · 11-point Numeric Rating Scale of Pain Intensity · Usage of Baseline and Rescue Analgesics in Previous 24 Hours · Patient Global Impression of Change Scale | Day 8, Day 28, Month 12 |
Countries
United States
Participant flow
Recruitment details
Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.
Participants by arm
| Arm | Count |
|---|---|
| Active 3-7 days of perineural local anesthetic infusion
perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h | 1 |
| Placebo 3-7 days of perineural normal saline infusion
normal saline (placebo): the basal rate will be set at 7 mL/h | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Research coordinator didn't collect data | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Active | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 23 years | 24 years | 23.5 years |
| Region of Enrollment United States | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement
Time frame: Week 4
Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.
Secondary
Emotional Functioning · Beck Depression Inventory
Time frame: pre-intervention; and then day 28 and 365 post-intervention
Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.
Secondary
Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure
Time frame: pre-intervention; and then 8 and 28 days post-intervention
Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.
Secondary
Pain · 11-point Numeric Rating Scale of Pain Intensity · Usage of Baseline and Rescue Analgesics in Previous 24 Hours · Patient Global Impression of Change Scale
Time frame: Day 8, Day 28, Month 12
Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.
Secondary
Physical Functioning · Brief Pain Inventory
Time frame: pre-intervention, then days 1, 3, 8, 28, 84, and 365
Population: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected \[coordinator simply did not collect the data\] and so this pilot study was closed without producing results.