Pregabalin in the Prevention of Postoperative Delirium and Pain

NCT ID: NCT00819988

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

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.

Conditions

Delirium; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar pill

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

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Pregabalin

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Sugar pill

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

Intervention Type: OTHER

Other Intervention Names

Lyrica

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Dr. A. Chaput

Clinician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan J Chaput, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Homer Yang, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital

Gregory L Bryson, MD, MSc

Role: STUDY_DIRECTOR

The Ottawa Hospital

Holly Evans, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital

Paul Beaule, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital

Prasad Jetty, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital

Barbara Power, MD

Role: STUDY_DIRECTOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

PMID: 2240918 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15370579 (View on PubMed)

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. doi: 10.1093/gerona/58.1.m76.

Reference Type: BACKGROUND

PMID: 12560416 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12817919 (View on PubMed)

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. doi: 10.1097/00000539-199804000-00019.

Reference Type: BACKGROUND

PMID: 9539601 (View on PubMed)

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. doi: 10.1007/BF03021846.

Reference Type: BACKGROUND

PMID: 16738290 (View on PubMed)

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. doi: 10.1155/2007/840572.

Reference Type: BACKGROUND

PMID: 17505569 (View on PubMed)

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. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16.

Reference Type: BACKGROUND

PMID: 16914695 (View on PubMed)

Other Identifiers

PSI2008525

Identifier Type: -

Identifier Source: org_study_id