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Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks

This study has been terminated.
(Could not secure funding to complete the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771862
First Posted: October 15, 2008
Last Update Posted: June 1, 2017
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.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
  Purpose
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.

Condition Intervention Phase
Amputation Phantom Limb Pain Stump Pain Procedure: perineural ropivicaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks

Further study details as provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:

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. [ Time Frame: Week 4 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: October 2008
Study Completion Date: May 30, 2017
Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1. standard care
1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.
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.
Active Comparator: 2: experimental care
4-5 days of perineural ropivacaine 0.4% infusion.
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.

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771862


Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Brian Ilfeld, M.D., M.S. University of California, San Diego
  More Information

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00771862     History of Changes
Other Study ID Numbers: Phantom limb pain PREVENTION
First Submitted: October 14, 2008
First Posted: October 15, 2008
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
pain
amputation
phantom limb
stump pain
catheter
nerve block
peripheral nerve block
ucsd
post-amputation phantom limb or stump pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms