Amputation, Phantom Limb Pain, Stump Pain
Conditions
Keywords
pain, amputation, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd, post-amputation phantom limb or stump pain
Brief summary
The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.
Detailed description
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain. Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment. Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Interventions
PROCEDUREperineural ropivicaine
Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h.
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively * currently without phantom limb and/or stump pain in a previously-amputated limb * ages 18 years or older * desiring perineural infusion for up to 6 days * willing to have an ambulatory infusion following hospital discharge
Exclusion criteria
* hepatic or renal failure * allergy to the study medications * pregnancy * incarceration * possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups. | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity) | Preoperative, then days 3, 8, 28, 84, and 365 |
| Emotional Functioning: Beck Depression Inventory | Preoperative, then days 28 and 365 |
| The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment. | 4 weeks |
Countries
United States
Outcome results
None listed