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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771862
• Other study ID #: Phantom Pain Prevention PILOT
• Status: Terminated
• Phase: Phase 4
• First received: October 14, 2008
• Last updated: March 15, 2018
• Start date: October 2008
• Est. completion date: May 30, 2017

Study information

• Verified date: March 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Phantom Limb
• Phantom Limb Pain
• Stump Pain

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD Medical Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Emotional Functioning: Beck Depression Inventory		Preoperative, then days 28 and 365
Secondary	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