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 1870 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
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
-
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.