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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00771862
First received: October 14, 2008
Last updated: July 25, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Emotional Functioning: Beck Depression Inventory [ Time Frame: Preoperative, then days 28 and 365 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2008
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771862

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

No publications provided

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
Study First Received: October 14, 2008
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on August 21, 2014