Pregabalin in the Prevention of Postoperative Delirium and Pain

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819988
• Other study ID #: PSI2008525
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2009
• Last updated: January 9, 2012
• Start date: May 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Pain

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)		postoperative day 1, 2, 3
Secondary	Interference with daily activities using BPI		postoperative day 3
Secondary	Pain at rest using NRS		postoperative days 1, 2, 3
Secondary	Pain with movement of the operative site using NRS		postoperative days 1, 2, 3
Secondary	Narcotic analgesic requirements		postoperative days 0, 1, 2, 3
Secondary	Sedation using RSS		postoperative days 1, 2, 3
Secondary	Narcotic-related adverse effects using ORSDS		postoperative days 1, 2, 3
Secondary	Recovery using the QoR		postoperative day 3
Secondary	Length of stay		Discharge day
Secondary	Medical Outcome Study (MOS) sleep score		Postoperative day 3