Condition category
Signs and Symptoms
Date applied
07/10/2005
Date assigned
20/10/2005
Last edited
13/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joseph Kay

ORCID ID

Contact details

Department of Anesthesia M3-200
Sunnybrook Health Sciences Centre
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
+1 416 480 4798
joseph.kay@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

1. Gabapentin administration reduces pain and opioid use postoperatively after total hip arthroplasty
2. Preoperative gabapentin is more effective than postoperative administration. This will definitively demonstrate the pre-emptive analgesic properties of gabapentin.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-emptive pain medication/postoperative pain control

Intervention

This is a prospective, randomized, double-blind, placebo-controlled study to compare total morphine consumption between the pre-emptive gabapentin, the postoperative gabapentin and the placebo groups. Patients will be randomly assigned to one of three treatment arms with 30 patients in each arm. Patients who are randomized to the preoperative gabapentin group will receive 600 mg orally (po) prior to surgery. The other two treatment arms will receive either placebo or gabapentin 600 mg 1 hour after their surgery is complete.

Intervention type

Drug

Phase

Not Applicable

Drug names

Gabapentin

Primary outcome measures

A comparison of the means of morphine consumption among the various treatment groups will be the primary outcome measure.

Secondary outcome measures

1. Visual Analog Scale (VAS) for pain will be used (0 = no pain, 100 = terrible pain)
2. Presence of nausea, vomiting, pruritis, and dizziness will be monitored at the same time intervals, and all except the latter treated as per the Acute Pain Service Nausea and Vomiting algorithm

Overall trial start date

01/01/2006

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Upon obtaining informed consent, patients with American Society of Anesthesiologists physical status I and II, of both genders, scheduled for hip arthroplasty will be recruited for this double-blinded, prospective, randomized, and placebo-controlled study. Patients must also be 18–70 years of age.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Patients not providing informed consent
2. Patients less than 18 years of age and greater than 75 years of age
3. Known allergy to any of the medications being used
4. History of drug or alcohol abuse
5. Patients with chronic pain on slow-release preparations of opioid
6. Patients with rheumatoid arthritis
7. Patients with psychiatric disorders
8. Patients unable or unwilling to use patient-controlled analgesia
9. Diabetic patients or those with impaired renal function (creatinine >106)
10. Obese patients (i.e., body mass index [BMI] >40)

Recruitment start date

01/01/2006

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Department of Anesthesia M3-200
Toronto
M4N 3M5
Canada

Sponsor information

Organisation

Sunnybrook Health Sciences Centre (Canada)

Sponsor details

Department of Anesthesia M3-200
2075 Bayview Ave.
Toronto
M4N 3M5
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19572933

Publication citations

  1. Results

    Clarke H, Pereira S, Kennedy D, Andrion J, Mitsakakis N, Gollish J, Katz J, Kay J, Adding gabapentin to a multimodal regimen does not reduce acute pain, opioid consumption or chronic pain after total hip arthroplasty., Acta Anaesthesiol Scand, 2009, 53, 8, 1073-1083, doi: 10.1111/j.1399-6576.2009.02039.x.

Additional files

Editorial Notes