Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

Condition(s) targeted: Lumbar Spinal Fusions

Intervention: Pregabalin 150 mg (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Michael Urban, MD, PhD, Phone: 212-606-1206, Email: urbanm@hss.edu

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

Secondary outcome:

Opioid Related Side Effects

Length of Hospital Stay

Opioid Consumption

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients for elective lumber posterior spinal fusions with segmental instrumentation

Exclusion Criteria:

- 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.

Michael Urban, MD, PhD, Phone: 212-606-1206, Email: urbanm@hss.edu

Hospital for Special Surgery, New York, New York 10021, United States; Recruiting
Michael Urban, MD, PhD, Principal Investigator

This is a link to our institution's homepage.

Related publications:

Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-74. Review.

Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-7. Review. No abstract available.

Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. Review.

Plasse M, Stahl JP, Rose-Pitet L, Joannard A, Guillen MC, Beaudoing A. [Neonatal septicemia and arthritis caused by an unusual germ]. Pediatrie. 1982 Jul-Aug;37(5):351-4. French. No abstract available.

Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. Review.

Gajraj NM. Pregabalin for pain management. Pain Pract. 2005 Jun;5(2):95-102.

Starting date: October 2008
Last updated: June 2, 2011