Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy? - Full Text View

Sponsor:	Sunnybrook Health Sciences Centre
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00982800

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: Gabapentin Drug: Placebo Sugar Pill	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Prostate Cancer

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

Will Gabapentin 200mg TID have pain and opioid sparing effects? [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Does postoperative Gabapentin have perioperative anxiety sparing effects and do these effects last beyond hospital discharge? [ Time Frame: up to 1 month postoperatively ] [ Designated as safety issue: No ]
3. Will improved analgesia with Gabapentin facilitate recovery and demonstrate effects on health related quality of life? [ Time Frame: up to 1 month postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2007
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982800

Locations

Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M5V 2W8

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

Study Chair:

Colin McCartney, MD

Sunnybrook Health Sciences Center

More Information

No publications provided

Responsible Party:	Jason Sawyer, Sunnybrook Health Sciences Corporation
ClinicalTrials.gov Identifier:	NCT00982800 History of Changes
Other Study ID Numbers:	075-2005
Study First Received:	September 22, 2009
Last Updated:	August 4, 2010
Health Authority:	Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:

gabapentin
opioid consumption
analgesic
anxiety
quality of life

Additional relevant MeSH terms:

Anxiety Disorders
Prostatic Neoplasms
Mental Disorders
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Gabapentin
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 09, 2012