Phantom Pain Clinical Trial
Official title:
Effects of Pre-operative Pregabalin and Ketamine to Prevent Development of Phantom Pain in Patients Undergoing Lower Extremity Amputation
Verified date | December 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 20, 2017 |
Est. primary completion date | September 20, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Ager 18-65 years old 2. Unilateral lower-limb amputations 3. Able to understand study procedures 4. If on opioids, patient should be on a stable dose for at least one week prior to enrolment. 5. Subject with normal renal function (CrCI > 60 mL/min). Exclusion Criteria: 1. Cases with only digits amputation 2. Current or recent history of alcohol and drug abuse 3. Concomitant use of CYP 3A4 medications 4. Unstable hypertension 5. Abnormal EKG 6. Increased intracranial pressure currently or in the past six months 7. Increased intraocular pressure currently or in the past six months 8. Liver disease or AST/ALT = 3 ULN or total bilirubin >2 x ULN 9. Poorly controlled psychiatric illness. 10. A history of seizure 11. Using other anticonvulsant drug 12. Renal impairment as determined by clinically significant labs 13. Women of childbearing age who either has: 1. A positive pregnancy test 2. Unprotected heterosexual sex since their previous menses or; 3. Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill) |
Country | Name | City | State |
---|---|---|---|
United States | Parkland Health Hospital System | Dallas | Texas |
United States | UTSW, Parkland Hospital | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Pain Scores (VAS) | Pain will be evaluated immediate postoperative period and 6 months after surgery | Postoperaive 6 months | |
Secondary | Oral analgesic consumption | Amounts of rescue analgesic use | 1 months after surgery |
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