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

NCT00771862 | Terminated Phase 4

• 1 other identifier: Phantom Pain Prevention PILOT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (3)

• Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)

  Preoperative, then days 3, 8, 28, 84, and 365

• Emotional Functioning: Beck Depression Inventory

  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.

  4 weeks

Study Arms (2)

1. standard care

PLACEBO COMPARATOR

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

Procedure: perineural ropivicaine

2: experimental care

ACTIVE COMPARATOR

4-5 days of perineural ropivacaine 0.4% infusion.

Procedure: perineural ropivicaine

Interventions

perineural ropivicaine PROCEDURE

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.

1. standard care; 2: experimental care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• hepatic or renal failure
• allergy to the study medications
• pregnancy
• incarceration
• possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Brian Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 15, 2008
• Study Start: October 1, 2008
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

US (1)