Condition category
Signs and Symptoms
Date applied
03/10/2005
Date assigned
25/10/2005
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

Perioperative gabapentin is effective in improving in-patient rehabilitation in the acute postoperative period at 6 weeks and possibly 3 months after Total Knee Arthroplasty (TKA) and reduces pain scores associated with rehabilitation.

Ethics approval

Ethics approval was received from the local medical ethics committee before trial recruitment began

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Rehabilitation medicine and perioperative pain control

Intervention

Patients will either receive perioperative gabapentin (n = 92) for five perioperative days or placebo pills (n = 92) for the intervention period within a multimodal analgesic regimen.

Therefore, patients will be given either placebo or gabapentin 600 mg two hours prior to surgery and then either placebo or gabapentin 200 mg twice daily starting 8 hours after their Pre-Operative Dose (POD).

Intervention type

Drug

Phase

Not Applicable

Drug names

Gabapentin

Primary outcome measures

1. Does perioperative gabapentin administration positively influence early rehabilitation and recovery of physical function? If so, are these effects maintained at 6 weeks and 3 months post surgery?
2. Does perioperative gabapentin administration reduce postoperative movement evoked pain associated with rehabilitation? If so, are these effects also maintained at 6 weeks and 3 months post surgery?

Secondary outcome measures

1. A comparison of the means of morphine consumption between the two groups will be an outcome measures
2. Numeric Rating Scale (NRS) for pain will be used (0 = no pain, 10 = worst possible pain). Data will be collected as described previously
3. Presence of nausea, vomiting, pruritus, 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
4. Sedation, as per the scale described above, at the same time intervals
5. A comparison of the Hospital Anxiety and Depression Scale (HADS) from baseline, POD 4, 6 weeks and 3 months
6. Health-related Quality of Life Scores from the Western Ontario McMaster Universities Osteoarthritis (WOMAC) index

Overall trial start date

02/01/2007

Overall trial end date

08/01/2008

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 total knee arthroplasty will be recruited for this double-blinded, prospective, randomised, and placebo-controlled study. Patients must also be 18–75 years of age.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

184

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 (PCA)
9. Diabetic patients or those with impaired renal function (Creatinine >106)
10. Obese patients (i.e., body mass index [BMI] >40)
11. Postoperatively, patients will be excluded if they have had additional operative procedures requiring a change in the usual rehabilitation protocol of care

Recruitment start date

02/01/2007

Recruitment end date

08/01/2008

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

http://mysw.sw.ca/ccm/bins/home.cfm

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

Publication citations

Additional files

Editorial Notes