Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?
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|ClinicalTrials.gov Identifier: NCT00982800|
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : August 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Gabapentin Drug: Placebo Sugar Pill||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does Postoperative Gabapentin Reduce Pain, Opioid Consumption & Anxiety & Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Placebo Comparator: Placebo Sugar Pill
Patients are stratified based on their initial pain score in the recovery room. patients with a pain numeric rating scale of greater than or equal to 7/10 are stratified to the "high" group. then randomized to receive gabapentin 200 mg tid x 9 doses, or placebo x 9 doses. Patients with a pain score equal to or less than 6/10 are stratified to the "low" group, then randomized to receive gabapentin 200mg tid x 9 doses or placebo x 9 doses.
All patients receive Acetaminophen 1gm every 6 hours for 3 days, Celecoxib 400mg as a loading dose then 200mg twice a day for 3 days. Patients also receive patient controlled analgesia (PCA) of hydromorphone for 24 hrs, then are transitioned to oxycodone 5-15 mg every 2 hours as needed.
Drug: Placebo Sugar Pill
|Active Comparator: Gabapentin 200 mg tid x 9 doses||
200mg 3x/day for 3 days (9 doses total)
Other Name: Neurontin
- Will Gabapentin 200mg TID have pain and opioid sparing effects? [ Time Frame: 3 days after surgery ]
- Does postoperative Gabapentin have perioperative anxiety sparing effects and do these effects last beyond hospital discharge? [ Time Frame: up to 1 month postoperatively ]
- 3. Will improved analgesia with Gabapentin facilitate recovery and demonstrate effects on health related quality of life? [ Time Frame: up to 1 month postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982800
|Sunnybrook Health Sciences Center|
|Toronto, Ontario, Canada, M5V 2W8|
|Study Chair:||Colin McCartney, MD||Sunnybrook Health Sciences Center|