- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01003704
Incidence of Phantom Limb Pain and Method of Anesthesia After Lower Extremity Amputation
October 28, 2009 updated by: North Texas Veterans Healthcare System
Phantom limb pain (pain originating from where an amputated limb once was) is a common occurrence after lower extremity amputations, with some sources noting incidence to be as high as 60-80% six months after surgery.
This pain can eventually subside, however, cases have been reported of incidence 10 years after surgery.
This pain is not only physically detrimental, but can also be psychologically detrimental after a difficult to accept change in the body.
Prior studies have been performed using regional anesthetic techniques (including spinals and epidurals) and different medications to attempt to reduce the incidence of phantom limb pain, however, the data have been mostly inconclusive.
Of interest, prior studies have not addressed peripheral nerve blocks, a method of anesthesia/analgesia more commonly employed for amputations recently.
The purpose of our retrospective study is to look at the incidence of phantom limb pain at our institution over a two year period to determine if peripheral nerve blocks result in a significantly reduced incidence compared to other techniques (spinal, epidural, general anesthesia only).
In addition, there is little data on relation of reason for amputation and presence of preoperative neuropathy and incidence of phantom pain.
As secondary endpoints, the investigators wish to investigate if certain reasons for amputation (trauma, peripheral vascular disease, diabetes, and others) and/or neuropathy lead to a higher incidence of phantom limb pain.
The results of this study could impact future management of patients who are to receive amputations and may lead to further prospective studies on the topics involved.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75216
- Veterans Affairs North Texas Health Care System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who receive lower extremity amputation
Description
Inclusion Criteria:
- Patients who receive lower extremity amputation
Exclusion Criteria:
- Death or incapacitating medical condition since surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
General Anesthesia only
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Peripheral nerve block
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spinal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 28, 2009
First Submitted That Met QC Criteria
October 28, 2009
First Posted (Estimate)
October 29, 2009
Study Record Updates
Last Update Posted (Estimate)
October 29, 2009
Last Update Submitted That Met QC Criteria
October 28, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Phantom Limb Pain
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Shirley Ryan AbilityLabCoapt, LLCRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper... and other conditionsUnited States
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Artur BiktimirovEnrolling by invitationAmputation | Phantom Limb Pain | Lower Limb Amputation | Phantom PainRussian Federation
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United States Naval Medical Center, San DiegoUnknownPhantom Limb Pain | Phantom Pain | Phantom Sensation | PseudomeliaUnited States
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VA Office of Research and DevelopmentRecruitingChronic Pain | Lower Limb Amputation | Phantom Pain | Upper Limb Amputation | Phantom Limb Pain After AmputationUnited States
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Artur BiktimirovEnrolling by invitationAmputation | Phantom Limb Pain | Phantom PainRussian Federation
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Centre d'Investigation Clinique et Technologique...CompletedAmputation | Phantom Pain Following Amputation of Lower LimbFrance
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University of California, San DiegoCompletedPhantom Limb Pain | Residual Limb PainUnited States
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University of California, San DiegoVarian Medical Systems; Epimed InternationalRecruitingAmputation, Traumatic | Phantom Limb Pain | Phantom Pain Following Amputation of Lower Limb | Amputation, SurgicalUnited States
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Cairo UniversityActive, not recruitingPhantom Pain Following Amputation of Lower LimbEgypt
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University of Alabama at BirminghamCompletedAmputation | Phantom Limb Pain | Residual Limb PainUnited States
Clinical Trials on Lower extremity amputation
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Dartmouth-Hitchcock Medical CenterDartmouth CollegeCompleted
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University Medical Center GroningenNational Institute for Public Health and the Environment (RIVM); Isala; Innofeet and other collaboratorsActive, not recruitingDiabetes Mellitus | Lower Extremity AmputationsNetherlands
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University of California, San FranciscoCompletedLower Extremity AmputationUnited States
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Spectrum Health HospitalsNovadaq Technologies ULC, now a part of StrykerCompletedLower Extremity Amputation | Wound Healing | Below Knee Amputation | Above Knee AmputationUnited States
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Stony Brook UniversityCompletedMultiple SclerosisUnited States
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Helsinki University Central HospitalCompletedAmputation StumpFinland
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Dartmouth-Hitchcock Medical CenterDartmouth CollegeRecruitingCompartment Syndromes | Compartment Syndrome of Forearm | Compartment Syndrome of Lower LegUnited States
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Dartmouth-Hitchcock Medical CenterDartmouth CollegeRecruiting
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Hospital Angeles del PedregalCompletedLymphedema, Secondary | Lymphedema of Leg | Granuloma, Foreign-BodyMexico
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Parker UniversityUniversity of Miami; University of Houston; Whittier UniversityCompleted