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

NCT00768248 | Terminated Results

• 1 other identifier: NMCSD Phantom Pilot
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Phantom Limb; Stump Pain

Keywords

pain; phantom limb; stump pain; catheter; nerve block; peripheral nerve block; NMCSD; Post-Amputation Phantom Limb or Stump Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Active

ACTIVE COMPARATOR

3-7 days of perineural local anesthetic infusion

Drug: perineural ropivacaine

Placebo

PLACEBO COMPARATOR

3-7 days of perineural normal saline infusion

Drug: normal saline (placebo)

Interventions

perineural ropivacaine DRUG

ropivacaine 0.4%; the basal rate will be set at 7 mL/h

Active

normal saline (placebo) DRUG

the basal rate will be set at 7 mL/h

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Phantom Limb; Pain

Interventions

Saline Solution

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University California San Diego

bilfeld@ucsd.edu

858-822-0776

Study Officials

• Steven Hanling, M.D.

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 13, 2019
• Results First Posted: August 13, 2019

Record last verified: 2019-07

Locations

US (1)