Pregabalin in the Prevention of Postoperative Delirium and Pain

Study Overview
=================
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.

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

Conditions
-----------------
Delirium, Pain

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Other: Sugar pill


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill<br>Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively | Other: Sugar pill<br>* Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively<br>|
| Experimental: Pregabalin<br>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<br>* 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<br>* Other names: Lyrica;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) |  | postoperative day 1, 2, 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative, Perioperative, Orthopedic surgery, Vascular surgery, Gabapentinoid