Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lumbar Spinal Fusions
Intervention: Pregabalin 150 mg (Drug); Placebo (Drug)
Phase: Phase 4
Sponsored by: Hospital for Special Surgery, New York
Official(s) and/or principal investigator(s):
Michael K Urban, MD, PhD, Principal Investigator, Affiliation: Hospital for Special Surgery, New York
Acute pain management is challenging in patients after spinal fusions, particularly since
most have taken analgesics for prolonged periods before choosing the surgical alternative.
Many of these patients are either preoperatively or become after surgery narcotic dependent.
In addition, the narcotic based anesthetic required for the procedure, may induce a
postoperative hyper-analgesia which may be partially responsible for the acute postoperative
pain which is refractory to traditional doses of narcotics. Both the persistent nociceptive
and neuropathic pain which these patients experience and narcotic-induced hyper-analgesia is
mediated via non-conventional neural pathways. It is for these reasons, that in these
patients postoperative pain is refractory to narcotic treatment. Postoperative pain in this
situation is best managed using a multimodal approach. This technique allows the
application of a number of treatment modalities which maximize pain reduction and minimize
treatment side effects.
Pregabalin (Lyrica) has been shown to be effective in the treatment of neuropathic pain.
Pregabalin has a similar mechanism of action as gabapentin. Notably it has a rapid
consistent absorption, linear pharmacokinetics, and a low potential for pharmacokinetic drug
interactions. Hence, pregabalin should be a beneficial addition to the multi-modal pain
regimen after spinal surgery; particularly in narcotic tolerant patients who respond poorly
to conventional narcotic analgesics after surgery.
Hypothesis: Patients treated with Pregabalin after posterior-spinal fusions will have: 1)
reduced pain at rest and with physical therapy, and 2) reduced narcotic requirements with
fewer narcotic related side-effects than controls treated with Pregabalin. This may result
in a shorter hospital stay (the mean length of stay for 1-2 level posterior lumbar-sacral
fusions with instrumentation at our institution is 4. 9±2 days).
Official title: Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain Scores
Opioid Related Side Effects
Length of Hospital Stay
Minimum age: 21 Years.
Maximum age: 80 Years.
- Patients for elective lumber posterior spinal fusions with segmental instrumentation
- Use of pregabalin or gabapentin within the washout period. Some chronic pain patients
should not be subjected to a washout period for either medication prior to surgery,
as determined by their pain management physician, and these patients will be excluded
from the study.
- Allergic sensitivity to pregabalin.
- Renal insufficiency, Cr ≥ 1. 5 mg/dl.
- Active substance abuse.
- Unstable mental condition.
- Non English Speaking Patients.
Locations and Contacts
Hospital for Special Surgery, New York, New York 10021, United States
This is a link to our institution's homepage.
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Starting date: October 2008
Last updated: July 23, 2012