NCT00819988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

January 8, 2009

Last Update Submit

January 9, 2012

Conditions

DeliriumPain

Keywords

PostoperativePerioperativeOrthopedic surgeryVascular surgeryGabapentinoid

Outcome Measures

Primary Outcomes (1)

  • Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)

    postoperative day 1, 2, 3

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

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

Other: Sugar pill

Pregabalin

EXPERIMENTAL

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

Interventions

PregabalinDRUG

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

Also known as: Lyrica
Pregabalin
Sugar pillOTHER

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

Sugar pill

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 years and older
  • booked for major orthopaedic or vascular procedure
  • expected length of stay \> 2 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (8)

  • 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. doi: 10.7326/0003-4819-113-12-941.

    PMID: 2240918BACKGROUND

  • 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. doi: 10.1080/00016470410001123.

    PMID: 15370579BACKGROUND

  • 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.

    PMID: 12560416BACKGROUND

  • Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.

    PMID: 12817919BACKGROUND

  • 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.

    PMID: 9539601BACKGROUND

  • 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.

    PMID: 16738290BACKGROUND

  • 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.

    PMID: 17505569BACKGROUND

  • 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.

    PMID: 16914695BACKGROUND

MeSH Terms

Conditions

DeliriumPain

Interventions

PregabalinSugars

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • Alan J Chaput, MD, MSc

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

  • Homer Yang, MD

    The Ottawa Hospital

    STUDY DIRECTOR

  • Gregory L Bryson, MD, MSc

    The Ottawa Hospital

    STUDY DIRECTOR

  • Holly Evans, MD

    The Ottawa Hospital

    STUDY DIRECTOR

  • Paul Beaule, MD

    The Ottawa Hospital

    STUDY DIRECTOR

  • Prasad Jetty, MD

    The Ottawa Hospital

    STUDY DIRECTOR

  • Barbara Power, MD

    The Ottawa Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Investigator

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations

CA(1)