Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Diego
Collaborator:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00771862
First received: October 14, 2008
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amputation Phantom Limb Pain Stump Pain |
Procedure: perineural ropivicaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks |
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- 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. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity) [ Time Frame: Preoperative, then days 3, 8, 28, 84, and 365 ] [ Designated as safety issue: No ]
- Emotional Functioning: Beck Depression Inventory [ Time Frame: Preoperative, then days 28 and 365 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771862
Locations
| United States, California | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Principal Investigator: | Brian Ilfeld, M.D., M.S. | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00771862 History of Changes |
| Other Study ID Numbers: | Phantom limb pain PREVENTION |
| Study First Received: | October 14, 2008 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
pain amputation phantom limb stump pain catheter |
nerve block peripheral nerve block ucsd post-amputation phantom limb or stump pain |
Additional relevant MeSH terms:
|
Phantom Limb Perceptual Disorders Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013