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NCT Number: NCT02464813

Effect of Pregabalin on Immediate Post-operative and Longterm Pain

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.

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Key information

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Turku University Hospital

Turku, 20521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescent (10-21 years) undergoing spinal fusion for idiopathic scoliosis, spondylolisthesis or Scheuermann kyphosis.
  • Posterior spinal fusion
  • No contraindication for Pregabalin use
  • ASA I-III
  • Written informed consent

Exclusion criteria

  • Other spinal pathology or other associated medical condition
  • Major neurologic developmental delay
  • Need for anterior surgery or for vertebral column resection.
  • Preoperative opioid use
  • Inability to use PCA

Treatment and study plan

Pregabalin

Drug

Patients will receive pregabalin twice preoperatively and twice daily for 5 days after surgery.

Other names: Lyrica

Sugar pill

Drug

Patients will receive placebo twice preoperatively and twice daily for 5 days after surgery.

Other names: placebo

Oxycodone

Drug

All patients will receive oxycodone as analgetic treatment administered by PCA. Oxycodone consumption will be measured.

Primary outcomes

  1. Postoperative pain measured in oxycodone consumption

    Time frame: 0-48h postoperatively

    All patients will receive oxycodone as analgesia administered using PCA. The oxycodone consumption will be recorded every 8 h. All adverse effects will be recorded. The oxycodone consumption will be measured in mg/kg/d.

Secondary outcomes

  1. Effect on neurophysiological measurements during spinal surgery

    Time frame: First 24 h.

    As a golden standard motor evoked potentials will be recorded and measured during surgery. The latency, amplitude and currency needed to evoke the potentials will be recorded.

  2. Effect on incidence of longterm pain

    Time frame: 2 years after surgery

    At the 2 year follow-up the patients will answer a pain questionnaire, Oswestry Low Back Pain Questionnaire and a pain drawing. The incidence of longterm pain after surgery will be evaluated.

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

Effect of Pregabalin on Immediate Post-operative and Longterm Pain and Spinal Cord Monitoring in Children Undergoing Instrumented Spinal Surgery.

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 8, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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