Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
San Diego, California, Forenede Stater, 92134
- Naval Medical Center San Diego
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Active
3-7 days of perineural local anesthetic infusion
|
ropivacaine 0.4%; the basal rate will be set at 7 mL/h
|
|
Placebo komparator: Placebo
3-7 days of perineural normal saline infusion
|
the basal rate will be set at 7 mL/h
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: Week 4
|
Week 4
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fysisk funktion · Kort smerteopgørelse
Tidsramme: præ-intervention, derefter dag 1, 3, 8, 28, 84 og 365
|
præ-intervention, derefter dag 1, 3, 8, 28, 84 og 365
|
|
Emotional Functioning · Beck Depression Inventory
Tidsramme: pre-intervention; and then day 28 and 365 post-intervention
|
pre-intervention; and then day 28 and 365 post-intervention
|
|
Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure
Tidsramme: pre-intervention; and then 8 and 28 days post-intervention
|
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
Tidsramme: Day 8, Day 28, Month 12
|
Day 8, Day 28, Month 12
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Steven Hanling, M.D., United States Naval Medical Center, San Diego
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i nervesystemet
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Perceptuelle forstyrrelser
- Smerter, postoperativ
- Fantomlem
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Bedøvelsesmidler, lokale
- Ropivacain
Andre undersøgelses-id-numre
- NMCSD Phantom Pilot
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .