Effect of Pregabalin on Immediate Post-operative and Longterm Pain

October 14, 2020 updated by: Ilkka Helenius, Turku University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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: Oxycodone
All patients will receive oxycodone as analgetic treatment administered by PCA. Oxycodone consumption will be measured.
Drug: Sugar pill
Patients will receive placebo twice preoperatively and twice daily for 5 days after surgery.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-48h postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 24 h.
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.
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T93/2015
  • 2015-000072-99 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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