Postoperative Pain Control for Prostatectomy (TAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00913068|
Recruitment Status : Unknown
Verified May 2009 by Nova Scotia Health Authority.
Recruitment status was: Not yet recruiting
First Posted : June 3, 2009
Last Update Posted : June 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Transverse Abdominal Plan (TAP) Procedure: standard post op pain control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, 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)|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||November 2010|
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.
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
Other Name: timed assessments for pain and medications
- 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 ]
- To evaluate the practical utility of a surgeon administered regional block during a radical prostatectomy [ Time Frame: during surgery ]
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): NCT00913068
|Contact: Ricardo A Rendon, MDemail@example.com|
|Canada, Nova Scotia|
|Queen Elizabeth Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Contact: Susan J Winch, BScN 902-473-6604 firstname.lastname@example.org|
|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|
|Principal Investigator:||Ricardo A Rendon, MD||Queen Elizabeth Health Sciences Centre|