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Effect of Pregabalin on Immediate Post-operative and Longterm Pain

NCT02464813 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Scoliosis
  • Spondylolisthesis

Interventions

DRUG

Pregabalin

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

DRUG

Sugar pill

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

DRUG

Oxycodone

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

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2018-08-31
Completion
2020-10-01

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464813 on ClinicalTrials.gov