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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771862
Recruitment Status : Terminated (Could not secure funding to complete the study.)
First Posted : October 15, 2008
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE October 14, 2008
First Posted Date  ICMJE October 15, 2008
Last Update Posted Date March 19, 2018
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
  • 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 ]
  • Emotional Functioning: Beck Depression Inventory [ Time Frame: 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. [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
Official Title  ICMJE Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Amputation
  • Phantom Limb Pain
  • Stump Pain
Intervention  ICMJE Procedure: perineural 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.
Study Arms  ICMJE
  • Placebo Comparator: 1. standard care
    1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.
    Intervention: Procedure: perineural ropivicaine
  • Active Comparator: 2: experimental care
    4-5 days of perineural ropivacaine 0.4% infusion.
    Intervention: Procedure: perineural ropivicaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 30, 2017)
16
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2008)
30
Actual Study Completion Date  ICMJE May 30, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771862
Other Study ID Numbers  ICMJE Phantom Pain Prevention PILOT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian M. Ilfeld, MD, MS, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE National Institute of General Medical Sciences (NIGMS)
Investigators  ICMJE
Principal Investigator: Brian Ilfeld, M.D., M.S. University of California, San Diego
PRS Account University of California, San Diego
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP