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Postoperative Pain Control for Prostatectomy (TAP)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transverse Abdominal Plan (TAP)
standard post op pain control
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring radical prostatectomy

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • prostate cancer for radical prostatectomy

Exclusion Criteria:

  • chronic pain or opiate use

Sites / Locations

  • Queen Elizabeth Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP arm

standard post operative pain control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Total Milligrams of Opiates
mean number of milligrams used postoperatively

Secondary Outcome Measures

Full Information

First Posted
June 1, 2009
Last Updated
September 3, 2021
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT00913068
Brief Title
Postoperative Pain Control for Prostatectomy
Acronym
TAP
Official Title
Post Operative Analgesia Using the Transverse Abdominal Plan (TAP) Block in Patients Undergoing a Radical Retropubic Prostatectomy (RRP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
radical prostatectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP arm
Arm Type
Experimental
Arm Description
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
Arm Title
standard post operative pain control
Arm Type
Active Comparator
Arm 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). 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 Type
Procedure
Intervention Name(s)
Transverse Abdominal Plan (TAP)
Other Intervention Name(s)
lidocaine, ropivacaine
Intervention Description
An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.
Intervention Type
Procedure
Intervention Name(s)
standard post op pain control
Other Intervention Name(s)
timed assessments for pain and medications
Intervention Description
opiates
Primary Outcome Measure Information:
Title
Total Milligrams of Opiates
Description
mean number of milligrams used postoperatively
Time Frame
2, 6,12, 24, 48 and 72 hours

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: prostate cancer for radical prostatectomy Exclusion Criteria: chronic pain or opiate use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A Rendon, MD
Organizational Affiliation
Queen Elizabeth Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada

12. IPD Sharing Statement

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Postoperative Pain Control for Prostatectomy

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