Pregabalin in the Prevention of Postoperative Delirium and Pain

Phase 3

Completed

• Conditions: Delirium; Pain
• Interventions: Other: Sugar pill; Drug: Pregabalin

• Registration Number: NCT00819988
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Study Start: 2009-05
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Sugar pill	Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
Pregabalin	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

Primary Outcome Measures

Name	Time	Method
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)	postoperative day 1, 2, 3

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada