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Effect of Pregabalin on Immediate Post-operative and Longterm Pain

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ClinicalTrials.gov Identifier: NCT02464813
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ilkka Helenius, Turku University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Scoliosis Spondylolisthesis Drug: Pregabalin Drug: Sugar pill Drug: Oxycodone Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Effect of Pregabalin on Immediate Post-operative and Longterm Pain and Spinal Cord Monitoring in Children Undergoing Instrumented Spinal Surgery.
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Pregabalin
Pregabalin in hard capsule 2mg/kg rounded up to next 25mg twice daily, max 150mg x 2, for 5 days.
Drug: Pregabalin
Patients will receive pregabalin twice preoperatively and twice daily for 5 days after surgery.
Other Name: Lyrica
Drug: Oxycodone
All patients will receive oxycodone as analgetic treatment administered by PCA. Oxycodone consumption will be measured.
Placebo Comparator: Sugar pill
Same hard capsule and same amount of tablets twice daily for 5 days.
Drug: Sugar pill
Patients will receive placebo twice preoperatively and twice daily for 5 days after surgery.
Other Name: placebo
Drug: Oxycodone
All patients will receive oxycodone as analgetic treatment administered by PCA. Oxycodone consumption will be measured.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464813


Contacts
Contact: Ilkka Helenius, MD ilkka.helenius@tyks.fi
Contact: Linda Helenius, ML linda.helenius@tyks.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Linda Helenius, MD         
Sponsors and Collaborators
Turku University Hospital

Responsible Party: Ilkka Helenius, Division Head, Turku University Hospital
ClinicalTrials.gov Identifier: NCT02464813     History of Changes
Other Study ID Numbers: T93/2015
2015-000072-99 ( EudraCT Number )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Ilkka Helenius, Turku University Hospital:
pregabalin
idiopathic scoliosis

Additional relevant MeSH terms:
Spondylolisthesis
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Pregabalin
Oxycodone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Opioid
Narcotics