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

NCT00982800 | Completed Phase 4 DMC

• 1 other identifier: 075-2005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

gabapentin; opioid consumption; analgesic; anxiety; quality of life

Outcome Measures

Primary Outcomes (1)

• Will Gabapentin 200mg TID have pain and opioid sparing effects?

  3 days after surgery

Secondary Outcomes (2)

• Does postoperative Gabapentin have perioperative anxiety sparing effects and do these effects last beyond hospital discharge?

  up to 1 month postoperatively

• 3. Will improved analgesia with Gabapentin facilitate recovery and demonstrate effects on health related quality of life?

  up to 1 month postoperatively

Study Arms (2)

Placebo Sugar Pill

PLACEBO COMPARATOR

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

Gabapentin 200 mg tid x 9 doses

ACTIVE COMPARATOR

Drug: Gabapentin

Interventions

Gabapentin DRUG

200mg 3x/day for 3 days (9 doses total)

Also known as: Neurontin

Gabapentin 200 mg tid x 9 doses

Placebo Sugar Pill DRUG

Placebo Sugar Pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, M5V 2W8, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Colin McCartney, MD

  Sunnybrook Health Sciences Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: June 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 6, 2010

Record last verified: 2010-08

Locations

CA (1)