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Completed

NCT Number: NCT00819988

Pregabalin in the Prevention of Postoperative Delirium and Pain

The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

Delirium is a common postoperative complication occurring in up to 73% of patients sometime during their hospital stay. Elderly patients undergoing major surgical procedures are at highest risk. While many risk factors for delirium are known, the specific pathophysiology of postoperative delirium remains unclear and is likely multifactorial. The most common inciting agents and events include metabolic causes, medications, blood loss, hypoxemia and pain. Pain and its management are intimately related to the likelihood of developing postoperative delirium. As a class, gabapentinoids, such as pregabalin, have proven to reduce postoperative pain and narcotic consumption and therefore may have a role to play in the prevention of postoperative delirium.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged 60 years and older
  • booked for major orthopaedic or vascular procedure
  • expected length of stay > 2 days

Exclusion criteria

  • open AAA repair
  • EVAR
  • allergy/sensitivity to pregabalin or gabapentin
  • use of pregabalin or gabapentin in previous 14 days
  • severe liver disease
  • severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent
  • seizure disorder
  • MMSE < 24/30
  • inability to speak English or French

Treatment and study plan

Pregabalin

Drug

Pregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function

Other names: Lyrica

Sugar Pill

Other

Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively

Primary outcomes

  1. Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)

    Time frame: postoperative day 1, 2, 3

Secondary outcomes

  1. Interference with daily activities using BPI

    Time frame: postoperative day 3

  2. Pain at rest using NRS

    Time frame: postoperative days 1, 2, 3

  3. Pain with movement of the operative site using NRS

    Time frame: postoperative days 1, 2, 3

  4. Narcotic analgesic requirements

    Time frame: postoperative days 0, 1, 2, 3

  5. Sedation using RSS

    Time frame: postoperative days 1, 2, 3

  6. Narcotic-related adverse effects using ORSDS

    Time frame: postoperative days 1, 2, 3

  7. Recovery using the QoR

    Time frame: postoperative day 3

  8. Length of stay

    Time frame: Discharge day

  9. Medical Outcome Study (MOS) sleep score

    Time frame: Postoperative day 3

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 9, 2009
Registry last updated
Jan 10, 2012

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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