Pre-operative Pregabalin and Ketamine to Prevent Phantom Pain
Status:
Withdrawn
Trial end date:
2017-09-20
Target enrollment:
Participant gender:
Summary
Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified
as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone
limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually
resistant to a wide variety of treatments (1-4). Three factors may contribute to the
development of persistent, post-amputation PLP by inducing central sensitization at different
times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute
postoperative pain (5-7).
Investigators hypothesis that pre-amputation period could be important in eliminating Phantom
Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The
reduction of pre-operative pain and prevention of formation of pain memories may eliminate
development of PLP by using dual networks treatment strategy. This Phase III, randomized,
double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative
pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing
lower limb amputation.