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
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92134
- Naval Medical Center San Diego
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: Week 4
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Week 4
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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신체 기능 · 간략한 통증 목록
기간: 개입 전, 1일, 3일, 8일, 28일, 84일 및 365일
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개입 전, 1일, 3일, 8일, 28일, 84일 및 365일
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Emotional Functioning · Beck Depression Inventory
기간: 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
기간: 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
기간: Day 8, Day 28, Month 12
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Day 8, Day 28, Month 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Steven Hanling, M.D., United States Naval Medical Center, San Diego
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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