Evaluation of gabapentin as a pre-emptive analgesic for patients undergoing total hip arthroplasty
| ISRCTN | ISRCTN14907042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14907042 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/10/2005
- Registration date
- 20/10/2005
- Last edited
- 13/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joseph Kay
Scientific
Scientific
Department of Anesthesia M3-200
Sunnybrook Health Sciences Centre
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
| Phone | +1 416 480 4798 |
|---|---|
| joseph.kay@utoronto.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gabapentin |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Anesthesia M3-200
Toronto
M4N 3M5
Canada
M4N 3M5
Canada
Sponsor information
Sunnybrook Health Sciences Centre (Canada)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesia M3-200
2075 Bayview Ave.
Toronto
M4N 3M5
Canada
"ROR" |
https://ror.org/03wefcv03 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No |
