Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study

Conditions
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Amputation, Phantom Limb Pain, Stump Pain

Intervention / Treatment
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* Procedure: perineural ropivicaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1. standard care<br>1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion. | Procedure: perineural ropivicaine<br>* 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.<br>|
| Active Comparator: 2: experimental care<br>4-5 days of perineural ropivacaine 0.4% infusion. | Procedure: perineural ropivicaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, amputation, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd, post-amputation phantom limb or stump pain