Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
Condition: Lumbar Spinal Fusions
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The treatment of postoperative pain continues to be a challenge, particularly after posterior
      spinal fusions. Many of these patients have been treated with analgesics or other modalities
      for prolonged periods before choosing the surgical alternative. In addition, the
      narcotic-based anesthetic required for the procedure may induce postoperative
      hyper-analgesia. Inadequate treatment of this pain can result in prolonged hospitalization,
      cardiopulmonary complications, and poor surgical outcome. However, the narcotic treatment of
      pain is often associated with multiple adverse effects. Multimodal postoperative analgesia
      has been instituted to reduce pain while limiting the adverse side effects of opioids.
      Pregabalin has been shown to be efficacious in the management of chronic pain syndromes with
      limited adverse side effects. Hence, multiple studies have attempted to demonstrate the
      benefits of including pregabalin in multimodal postoperative pain management. These studies
      have yielded conflicting results with regard to reduced pain, opioid consumption, and
      improved outcome. We propose that the addition of pregabalin to acute pain regimen after
      posterior spinal fusions should reduce narcotic requirements and hence improve outcome by
      reducing narcoticinduced side effects. Although recent studies have also examined the
      administration of pregabalin after spinal fusions, this study was conducted with a uniform
      anesthetic regimen and similar procedure performed by two spine surgeons at one institution.
      Pain scores were controlled as well as physical therapy milestones to assess whether changes
      in the pain regimen would affect narcotic consumption, narcotic induced side effects, and
      length of hospitalization.
    

Intervention name(s): Pregabalin 150 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14.; Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthopedic Procedures; Spinal Fusions; Pregabalin; Gamma-Aminobutyric Acid; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Central Nervous System Agents; Therapeutic Uses; Anticonvulsants; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action