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

This study has been completed.
Sponsor:
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01003704
First received: October 28, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 28, 2009
Last Updated: October 28, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014