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Postoperative Pain Control for Prostatectomy (TAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00913068
First received: June 1, 2009
Last updated: June 2, 2009
Last verified: May 2009

June 1, 2009
June 2, 2009
July 2009
August 2010   (final data collection date for primary outcome measure)
To investigate the analgesic efficacy and safety of the TAP block, in comparison to our standard of care in the peri-operative setting. [ Time Frame: assessments along with patients' vitals will be completed at 2, 6, 12, 24, 48 and 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00913068 on ClinicalTrials.gov Archive Site
To evaluate the practical utility of a surgeon administered regional block during a radical prostatectomy [ Time Frame: during surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Postoperative Pain Control for Prostatectomy
Post Operative Analgesia Using the Transverse Abdominal Plan (TAP) Block in Patients Undergoing a Radical Retropubic Prostatectomy (RRP)

The researchers propose to investigate a relatively new anesthetic procedure, in order to maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.

Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). As the amount of opiates used can be significant, we have to be aware of their inherent risks. Opiates have an excellent pain control profile, working peripherally by decreasing the amount of neurotransmitters released from neurons involving noxious stimuli, and also in their central processing. Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.

Thus we propose the use of a relatively new regional anesthetic technique be employed to further decrease the need for opiates in our prostatectomy patients' post-op course, while adequately controlling their pain.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Prostate Cancer
  • Procedure: Transverse Abdominal Plan (TAP)
    An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.
    Other Names:
    • lidocaine
    • ropivacaine
  • Procedure: standard post op pain control
    opiates
    Other Name: timed assessments for pain and medications
  • Experimental: TAP arm
    in the experimental arm, the procedure will consist of the staff urologist injecting local anesthetic into the anterior abdominal wall bilaterally from the inside of the abdomen at the end of their surgery
    Intervention: Procedure: Transverse Abdominal Plan (TAP)
  • Active Comparator: standard post operative pain control
    Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
    Intervention: Procedure: standard post op pain control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
November 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • prostate cancer for radical prostatectomy

Exclusion Criteria:

  • chronic pain or opiate use
Male
up to 80 Years
No
Contact: Ricardo A Rendon, MD 902-425-3940 rrendon@dal.ca
Canada
 
NCT00913068
version 1September 102008
No
Dr Ricardo Rendon, Queen Elizabeth Health sciences Centre
Capital District Health Authority, Canada
Not Provided
Principal Investigator: Ricardo A Rendon, MD Queen Elizabeth Health Sciences Centre
Capital District Health Authority, Canada
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP