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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00913068
Other study ID # version 2 July 13, 2009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2009
Est. completion date September 2011

Study information

Verified date September 2021
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Male
Age group N/A to 80 Years
Eligibility Inclusion Criteria: - prostate cancer for radical prostatectomy Exclusion Criteria: - chronic pain or opiate use

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transverse Abdominal Plan (TAP)
An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.
standard post op pain control
opiates

Locations

Country Name City State
Canada Queen Elizabeth Health Sciences Centre Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Milligrams of Opiates mean number of milligrams used postoperatively 2, 6,12, 24, 48 and 72 hours
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