Effect of Pregabalin on Immediate Post-operative and Longterm Pain
Condition: Scoliosis; Spondylolisthesis
MeSH terms: Scoliosis; Spondylolisthesis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the incidence of longterm pain after spinal fusion surgery in
      children and adolescents. In the second part of the study a randomized double-blind clinical
      trial will be conducted. We compare the effect of pregabalin versus placebo on postoperative
      pain and oxycodone consumption. We will also be able to evaluate the effect of pregabalin on
      neurophysiological monitoring during surgery.
    

Detailed description: 
      Adolescent idiopathic scoliosis is the most common indication for major surgery during
      adolescence. Postoperative pain is a major concern in these adolescents with major surgical
      trauma. Spinal cord monitoring is an essential part of spinal deformity correction, but the
      effects of pregabalin on these measurements are not known.

      In order to evaluate the incidence of longterm postoperative pain in children after spinal
      surgery the first part of our study will be retrospective. We will send a symptom and pain
      questionnaire to all children, who have been in spinal fusion surgery at our university
      hospital between the years 2009-2015. The questionnaire will include Oswestry Low Back Pain
      Questionnaire, pain drawing and SRS-24. The Oswestry Disability Index is currently considered
      by many as the gold standard for measuring degree of disability and estimating quality of
      life in a person with low back pain.

      In the second part of our study a randomized double-blind clinical trial will be conducted
      comparing the effect of pregabalin and placebo on postoperative pain and oxycodone
      consumption. In addition the effect of pregabalin on neurophysiological monitoring in
      adolescents undergoing surgery for spinal deformities will be assessed. Finally, the
      prevalence of persistent postsurgical pain will be evaluated at 6, 12 and 24 months after
      surgery.

      To obtain statistical power of 80% and a type I-error level of 0.05, 60 adolescents (30 in
      control and 30 in active treatment group) will be recruited according to CONSORT guidelines.

      The aim of the study is to evaluate the effect of pregabalin given twice preoperatively and
      for five days postoperatively on postoperative pain. Pain will be measured using visual
      analogue scale (VAS). Oxycodone administered using patient controlled anesthesia (PCA) will
      be used for analgesia. Persistent pain at 6, 12 and 24 months will also be evaluated. In
      addition, the effect of preoperative pregabalin on motor evoked potentials (latency,
      amplitude, currency needed to evoke potentials) during spinal cord monitoring as well as
      perioperative EEG findings and on the consumption of anesthetics.
    

Intervention name(s): Pregabalin; Sugar pill; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive pregabalin twice preoperatively and twice daily for 5 days after surgery.; Patients will receive placebo twice preoperatively and twice daily for 5 days after surgery.; All patients will receive oxycodone as analgetic treatment administered by PCA. Oxycodone consumption will be measured.
Other intervention name(s): Lyrica; placebo
Intervention MeSH terms: Pregabalin; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: pregabalin; idiopathic scoliosis