Pregabalin in the Prevention of Postoperative Delirium and Pain - Full Text View

Sponsors and Collaborators:	Ottawa Health Research Institute Pfizer
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00819988

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 III

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

Delirium (CAM-ICU positive) [ 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 ]

Estimated Enrollment:	140
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sugar pill: Placebo Comparator 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
Pregabalin: Experimental 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

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

Contacts

Contact: Alan J Chaput, MD, MSc	613-761-4169	achaput@ottawahospital.on.ca
Contact: Gregory L Bryson, MD, MSc	613-761-4169	glbryson@ottawahospital.on.ca

Locations

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

Sponsors and Collaborators

Ottawa Health 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:

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8.

Bitsch M, Foss N, Kristensen B, Kehlet H. Pathogenesis of and management strategies for postoperative delirium after hip fracture: a review. Acta Orthop Scand. 2004 Aug;75(4):378-89. Review.

Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81.

Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. Review.

Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5.

Gilron I. Review article: the role of anticonvulsant drugs in postoperative pain management: a bench-to-bedside perspective. Can J Anaesth. 2006 Jun;53(6):562-71. Review.

Peng PW, Wijeysundera DN, Li CC. Use of gabapentin for perioperative pain control -- a meta-analysis. Pain Res Manag. 2007 Summer;12(2):85-92.

Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. Epub 2006 Aug 16.

Responsible Party:	Ottawa Health Research Institute ( Alan J. Chaput, Clinical Investigator )
Study ID Numbers:	PSI2008525
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819988
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

Postoperative
Perioperative
Orthopedic surgery
Vascular surgery
Gabapentinoid

Study placed in the following topic categories:

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pregabalin
Neurologic Manifestations
Confusion

Pain
Dementia
Neurobehavioral Manifestations
Cognition Disorders
Pain, Postoperative
Delirium

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009