Effect of Pregabalin on Immediate Post-operative and Longterm Pain

NCT02464813 | Completed Phase 4 DMC

• 2 other identifiers: T93/20152015-000072-99
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Spondylolisthesis

Keywords

pregabalin; idiopathic scoliosis

Outcome Measures

Primary Outcomes (1)

• Postoperative pain measured in oxycodone consumption

  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 Outcomes (2)

• Effect on neurophysiological measurements during spinal surgery

  First 24 h.

• Effect on incidence of longterm pain

  2 years after surgery

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Pregabalin in hard capsule 2mg/kg rounded up to next 25mg twice daily, max 150mg x 2, for 5 days.

Drug: Pregabalin; Drug: Oxycodone

Sugar pill

PLACEBO COMPARATOR

Same hard capsule and same amount of tablets twice daily for 5 days.

Drug: Sugar pill; Drug: Oxycodone

Interventions

Pregabalin DRUG

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

Also known as: Lyrica

Pregabalin

Sugar pill DRUG

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

Also known as: placebo

Sugar pill

Oxycodone DRUG

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

Pregabalin; Sugar pill

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Scoliosis; Spondylolisthesis

Interventions

Pregabalin; Sugars; Oxycodone

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: June 8, 2015
• Study Start: August 1, 2015
• Primary Completion: August 31, 2018
• Study Completion: October 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

FI (1)