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

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.

Study Overview

• Status: Terminated
• Conditions: Amputation; Phantom Limb Pain; Stump Pain
• Intervention / Treatment: Procedure: perineural ropivicaine

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: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Brian Ilfeld, M.D., M.S., University of California, San Diego

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): May 30, 2017
• Study Completion (ACTUAL): May 30, 2017

Study Registration Dates

• First Submitted: October 14, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (ESTIMATE): October 15, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: pain; nerve block; amputation; catheter; stump pain; phantom limb; peripheral nerve block; ucsd; post-amputation phantom limb or stump pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: Phantom Pain Prevention PILOT