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Incidence of Phantom Limb Pain and Method of Anesthesia After Lower Extremity Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01003704
First Posted: October 29, 2009
Last Update Posted: October 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
North Texas Veterans Healthcare System
  Purpose
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.

Condition Intervention
Phantom Limb Pain Procedure: Lower extremity amputation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Incidence of Phantom Limb Pain and Method of Anesthesia After Lower Extremity Amputation

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Groups/Cohorts Assigned Interventions
General Anesthesia only Procedure: Lower extremity amputation
Peripheral nerve block Procedure: Lower extremity amputation
spinal Procedure: Lower extremity amputation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who receive lower extremity amputation
Criteria

Inclusion Criteria:

  • Patients who receive lower extremity amputation

Exclusion Criteria:

  • Death or incapacitating medical condition since surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003704


Locations
United States, Texas
Veterans Affairs North Texas Health Care System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
  More Information

Responsible Party: Chandramouli Iyer, MD, Veterans Affairs North Texas Health Care System
ClinicalTrials.gov Identifier: NCT01003704     History of Changes
Other Study ID Numbers: 09-059
First Submitted: October 28, 2009
First Posted: October 29, 2009
Last Update Posted: October 29, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs