Project III consists of three studies with the broad, long-term objectives of increasing scientific understanding of the prevalence, nature, and scope of the chronic pain problems associates with acquired amputation and determining the effectiveness of treatments for preventing and managing these problems.
The specific aim of Study 1 is to assess the efficacy of preoperative epidural anesthesia in the prevention of chronic phantom limb pain through a placebo controlled clinical trial. In Study 1, 125 individuals who are admitted for lower limb amputations will be randomly assigned to (1) receive lower limb anesthesia by a spinal epidural to eliminate pain prior to, and for 72 hours after surgery or (2) receive a """"""""sham"""""""" lumbar epidural catheter. All subjects in the treatment group will also receive patient controlled analgesia for up to 5-7 days postoperativelly. Assessment of pain, psychosocial and physical functioning will be performed for 2 years following the surgery. Analyses of postsurgical measures will test two hypotheses: (1) administration of effective preoperative epidural anesthesia reduces the incidence and severity of phantom limb pain and improves psychosocial and physical functioning extending to two years after amputation surgery and (2) adequate treatment of early postamputation pain predicts a lower incidence and severity of pain two years after amputation.
The aim of Study 2 is to ascertain the frequency and characteristics of painful and nonpainful sensations associated with amputation. In Study 2, questionnaires will be administered to a large sample of persons with acquired amputation to gain knowledge concerning the duration, intensity, frequency, quality and location of phantom limb pain, stump pain, and nonpainful sensations. Study 3 is a prospective, double-blind, randomized controlled clinical trial to evaluate, as compared to placebo, the effectiveness of amitriptyline in relieving chronic pain associated with amputation. The hypothesis to be tested in Study 3 is that amitriptyline is more effective than placebo in relieving chronic phantom limb and stump pain. Exploratory analyses will examine the relationship between outcome and specific covariates including demographic variables, biologic variables, drug level, pretreatment pain level and characteristics, and depression level. The results of the exploratory analyses may be used to develop hypotheses concerning the mechanisms by which particular medications may improve pain problems in persons with acquired amputation.
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