Pregabalin in the Prevention of Postoperative Delirium and Pain

January 9, 2012 updated by: Dr. A. Chaput, Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

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

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa 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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
Other: Sugar pill
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
Experimental: Pregabalin
Single dose of 75 mg given 30-60 minutes preoperatively, then 50 mg every 8 hours for 3 days postoperatively if creatinine clearance > 60 ml/min OR 25 mg every 8 hours for 3 days postoperatively if creatinine clearance 30-60 ml/min
Drug: Pregabalin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
Time Frame: postoperative day 1, 2, 3
postoperative day 1, 2, 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Interference with daily activities using BPI
Time Frame: postoperative day 3
postoperative day 3
Pain at rest using NRS
Time Frame: postoperative days 1, 2, 3
postoperative days 1, 2, 3
Pain with movement of the operative site using NRS
Time Frame: postoperative days 1, 2, 3
postoperative days 1, 2, 3
Narcotic analgesic requirements
Time Frame: postoperative days 0, 1, 2, 3
postoperative days 0, 1, 2, 3
Sedation using RSS
Time Frame: postoperative days 1, 2, 3
postoperative days 1, 2, 3
Narcotic-related adverse effects using ORSDS
Time Frame: postoperative days 1, 2, 3
postoperative days 1, 2, 3
Recovery using the QoR
Time Frame: postoperative day 3
postoperative day 3
Length of stay
Time Frame: Discharge day
Discharge day
Medical Outcome Study (MOS) sleep score
Time Frame: Postoperative day 3
Postoperative day 3

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

Collaborators

Pfizer

Investigators

  • Principal Investigator: Alan J Chaput, MD, MSc, The Ottawa Hospital
  • Study Director: Homer Yang, MD, The Ottawa Hospital
  • Study Director: Gregory L Bryson, MD, MSc, The Ottawa Hospital
  • Study Director: Holly Evans, MD, The Ottawa Hospital
  • Study Director: Paul Beaule, MD, The Ottawa Hospital
  • Study Director: Prasad Jetty, MD, The Ottawa Hospital
  • Study Director: Barbara Power, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSI2008525

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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