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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
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: Transverse Abdominal Plan (TAP)
Procedure: standard post op pain control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Post Operative Analgesia Using the Transverse Abdominal Plan (TAP) Block in Patients Undergoing a Radical Retropubic Prostatectomy (RRP)

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate the practical utility of a surgeon administered regional block during a radical prostatectomy [ Time Frame: during surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.
Procedure: standard post op pain control
opiates
Other Name: timed assessments for pain and medications

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prostate cancer for radical prostatectomy

Exclusion Criteria:

  • chronic pain or opiate use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913068

Contacts
Contact: Ricardo A Rendon, MD 902-425-3940 rrendon@dal.ca

Locations
Canada, Nova Scotia
Queen Elizabeth Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Susan J Winch, BScN    902-473-6604    susan.winch@cdha.nshealth.ca   
Sub-Investigator: Shuba De, MD         
Sub-Investigator: David G Bell, MD         
Principal Investigator: Ricardo A Rendon, MD         
Sub-Investigator: Joseph Lawen, MD         
Sub-Investigator: Greg Bailly, MD         
Sub-Investigator: Richard Norman, MD         
Sub-Investigator: John Grantmyre, MD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Ricardo A Rendon, MD Queen Elizabeth Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr Ricardo Rendon, Queen Elizabeth Health sciences Centre
ClinicalTrials.gov Identifier: NCT00913068     History of Changes
Other Study ID Numbers: version 1September 102008
Study First Received: June 1, 2009
Last Updated: June 2, 2009
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
radical prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014