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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
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:
The Acute Pain Service (APS) at Sunnybrook has been using Gabapentin 200 mg three times a day (TID) resulting in anecdotal benefits in terms of analgesia and opioid sparing effects. Higher doses of Gabapentin were associated with an increased incidence of sedation. The purpose of the study is to investigate if Gabapentin 200 mg given three times a day for 72 hours (9doses) results in a reduction in the total amount of opioid required after radical prostatectomy surgery as compared to placebo, and if analgesia is improved. This study will also examine the possible anxiety sparing effects and any health related quality of life (HRQL) changes, which may be a result of our perioperative use of gabapentin.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Gabapentin Drug: Placebo Sugar Pill Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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 Drug: Gabapentin
200mg 3x/day for 3 days (9 doses total)
Other Name: Neurontin




Primary Outcome Measures :
  1. Will Gabapentin 200mg TID have pain and opioid sparing effects? [ Time Frame: 3 days after surgery ]

Secondary Outcome Measures :
  1. Does postoperative Gabapentin have perioperative anxiety sparing effects and do these effects last beyond hospital discharge? [ Time Frame: up to 1 month postoperatively ]
  2. 3. Will improved analgesia with Gabapentin facilitate recovery and demonstrate effects on health related quality of life? [ Time Frame: up to 1 month postoperatively ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing radical prostatectomy
  • Able to read and write english (assistance is allowed)
  • Normal creatinine blood serum level
  • No known allergies to study medications

Exclusion Criteria:

  • Patients not providing informed consent
  • Patients less than 18 years of age or greater than 75 years of age
  • Known allergy to any of the medications being used
  • History of drug or alcohol abuse
  • Preoperative pain
  • Patients unable or unwilling to use PCA
  • Patients with impaired renal function (Creatinine >106)

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M5V 2W8
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Study Chair: Colin McCartney, MD Sunnybrook Health Sciences Center

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Responsible Party: Jason Sawyer, Sunnybrook Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT00982800    
Other Study ID Numbers: 075-2005
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: August 2010
Keywords provided by Sunnybrook Health Sciences Centre:
gabapentin
opioid consumption
analgesic
anxiety
quality of life
Additional relevant MeSH terms:
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Analgesics, Opioid
Gabapentin
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents