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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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California
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San Diego, California, Forente stater, 92134
- Naval Medical Center San Diego
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Active
3-7 days of perineural local anesthetic infusion
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ropivacaine 0.4%; the basal rate will be set at 7 mL/h
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Placebo komparator: Placebo
3-7 days of perineural normal saline infusion
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the basal rate will be set at 7 mL/h
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
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Week 4
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Fysisk funksjon · Kort smerteinventar
Tidsramme: pre-intervensjon, deretter dag 1, 3, 8, 28, 84 og 365
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pre-intervensjon, deretter dag 1, 3, 8, 28, 84 og 365
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Emotional Functioning · Beck Depression Inventory
Tidsramme: pre-intervention; and then day 28 and 365 post-intervention
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pre-intervention; and then day 28 and 365 post-intervention
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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
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pre-intervention; and then 8 and 28 days post-intervention
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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
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Day 8, Day 28, Month 12
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Steven Hanling, M.D., United States Naval Medical Center, San Diego
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdommer i nervesystemet
- Postoperative komplikasjoner
- Smerte
- Nevrologiske manifestasjoner
- Nevroatferdsmanifestasjoner
- Perseptuelle forstyrrelser
- Smerter, postoperativt
- Fantomlem
- Fysiologiske effekter av legemidler
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Sensoriske systemagenter
- Bedøvelsesmidler
- Anestesimidler, lokal
- Ropivakain
Andre studie-ID-numre
- NMCSD Phantom Pilot
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