Pregabalin in the Prevention of Postoperative Delirium and Pain

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. A. Chaput, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00819988
First received: January 8, 2009
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Delirium
Pain
Drug: Pregabalin
Other: Sugar pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) [ Time Frame: postoperative day 1, 2, 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interference with daily activities using BPI [ Time Frame: postoperative day 3 ] [ Designated as safety issue: No ]
  • Pain at rest using NRS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: No ]
  • Pain with movement of the operative site using NRS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: No ]
  • Narcotic analgesic requirements [ Time Frame: postoperative days 0, 1, 2, 3 ] [ Designated as safety issue: No ]
  • Sedation using RSS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: Yes ]
  • Narcotic-related adverse effects using ORSDS [ Time Frame: postoperative days 1, 2, 3 ] [ Designated as safety issue: Yes ]
  • Recovery using the QoR [ Time Frame: postoperative day 3 ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: Discharge day ] [ Designated as safety issue: Yes ]
  • Medical Outcome Study (MOS) sleep score [ Time Frame: Postoperative day 3 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: May 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lyrica

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819988

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
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
  More Information

Publications:

Responsible Party: Dr. A. Chaput, Clinician Investigator, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00819988     History of Changes
Other Study ID Numbers: PSI2008525
Study First Received: January 8, 2009
Last Updated: January 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Postoperative
Perioperative
Orthopedic surgery
Vascular surgery
Gabapentinoid

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 21, 2014