Status:
WITHDRAWN
Pre-operative Pregabalin and Ketamine to Prevent Phantom Pain
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Phantom Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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,...
Detailed Description
Patients undergoing unilateral lower extremity amputation (n=30) will be randomized in this double blind parallel placebo control clinical trial to evaluate the efficacy of pre-operative pregabalin (l...
Eligibility Criteria
Inclusion
- Ager 18-65 years old
- Unilateral lower-limb amputations
- Able to understand study procedures
- If on opioids, patient should be on a stable dose for at least one week prior to enrolment.
- Subject with normal renal function (CrCI \> 60 mL/min).
Exclusion
- Cases with only digits amputation
- Current or recent history of alcohol and drug abuse
- Concomitant use of CYP 3A4 medications
- Unstable hypertension
- Abnormal EKG
- Increased intracranial pressure currently or in the past six months
- Increased intraocular pressure currently or in the past six months
- Liver disease or AST/ALT ≥ 3 ULN or total bilirubin \>2 x ULN
- Poorly controlled psychiatric illness.
- A history of seizure
- Using other anticonvulsant drug
- Renal impairment as determined by clinically significant labs
- Women of childbearing age who either has:
- A positive pregnancy test
- Unprotected heterosexual sex since their previous menses or;
- Not currently using and/or willing to use a medically approved form of contraception (e.g., birth control pill)
Key Trial Info
Start Date :
May 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02311777
Start Date
May 15 2015
End Date
September 20 2017
Last Update
December 19 2018
Active Locations (2)
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1
Parkland Health Hospital System
Dallas, Texas, United States, 750390
2
UTSW, Parkland Hospital
Dallas, Texas, United States, 75390