Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain

The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.

Study Overview

• Status: Terminated
• Conditions: Amputation; Phantom Limb; Stump Pain
• Intervention / Treatment: Drug: perineural ropivacaine; Drug: normal saline (placebo)

Detailed Description

Specific Aim 1: To determine if, compared with current standard-of-care treatment, the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain.

Hypothesis 1: Following upper or lower extremity amputation, phantom limb and/or stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Specific Aim 2: To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb and/or stump pain and cortical reorganization.

Hypothesis 2: Following upper or lower extremity amputation with subsequent phantom limb pain/sensation and/or stump pain, the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion (as measured by MRI).

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego

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:

• previous upper or lower limb amputation including at least one metacarpal or metatarsal bone, respectively
• age 18 years or older
• phantom limb and/or stump pain described as at least a 2 on the NRS for the previous week [and pain occurring on a weekly basis over the previous month]
• willing to have an ambulatory perineural infusion for 6 days
• willing to avoid additional "new" analgesic interventions from 4 weeks prior to at least 4 weeks following catheter placement, and preferably to 6 months following catheter placement
• the availability of a "caretaker" who will transport the subject home following the procedure and remain with the subject for the first night of the infusion

Exclusion Criteria:

• known hepatic or renal insufficiency
• allergy to the study medications
• possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; 3-7 days of perineural local anesthetic infusion	Drug: perineural ropivacaine; ropivacaine 0.4%; the basal rate will be set at 7 mL/h
Placebo Comparator: Placebo; 3-7 days of perineural normal saline infusion	Drug: normal saline (placebo); the basal rate will be set at 7 mL/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Physical Functioning · Brief Pain Inventory	pre-intervention, then days 1, 3, 8, 28, 84, and 365
Emotional Functioning · Beck Depression Inventory	pre-intervention; and then day 28 and 365 post-intervention
Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure	pre-intervention; and then 8 and 28 days post-intervention
Pain · 11-point Numeric Rating Scale of Pain Intensity · Usage of Baseline and Rescue Analgesics in Previous 24 Hours · Patient Global Impression of Change Scale	Day 8, Day 28, Month 12

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Steven Hanling, M.D., United States Naval Medical Center, San Diego

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: pain; nerve block; catheter; stump pain; phantom limb; peripheral nerve block; NMCSD; 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; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: NMCSD Phantom Pilot