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

Primary Purpose

Amputation, Phantom Limb Pain, Stump Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
perineural ropivicaine
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Amputation focused on measuring pain, amputation, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd, post-amputation phantom limb or stump pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1. standard care

2: experimental care

Arm Description

1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.

4-5 days of perineural ropivacaine 0.4% infusion.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)
Emotional Functioning: Beck Depression Inventory
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.

Full Information

First Posted
October 14, 2008
Last Updated
March 15, 2018
Sponsor
University of California, San Diego
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00771862
Brief Title
Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
Official Title
Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Could not secure funding to complete the study.
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Phantom Limb Pain, Stump Pain
Keywords
pain, amputation, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd, post-amputation phantom limb or stump pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. standard care
Arm Type
Placebo Comparator
Arm Description
1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.
Arm Title
2: experimental care
Arm Type
Active Comparator
Arm Description
4-5 days of perineural ropivacaine 0.4% infusion.
Intervention Type
Procedure
Intervention Name(s)
perineural ropivicaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)
Time Frame
Preoperative, then days 3, 8, 28, 84, and 365
Title
Emotional Functioning: Beck Depression Inventory
Time Frame
Preoperative, then days 28 and 365
Title
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Ilfeld, M.D., M.S.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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

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