Pregabalin in the Prevention of Postoperative Delirium and Pain

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00819988

Enrollment

240

Registered

2009-01-09

Start date

2009-05-31

Completion date

2011-10-31

Last updated

2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Pain

Keywords

Postoperative, Perioperative, Orthopedic surgery, Vascular surgery, Gabapentinoid

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.

Interventions

DRUGPregabalin

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

OTHERSugar pill

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Interference with daily activities using BPI	postoperative day 3
Recovery using the QoR	postoperative day 3
Length of stay	Discharge day
Medical Outcome Study (MOS) sleep score	Postoperative day 3
Narcotic-related adverse effects using ORSDS	postoperative days 1, 2, 3

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026