Prostate CancerTAPNCT00913068
Postoperative Pain Control for Prostatectomy
A study testing Transverse Abdominal Plan (TAP) in people with Prostate Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Transverse Abdominal Plan (TAP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate cancer for radical prostatectomy
Who cannot join
- chronic pain or opiate use
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Transverse Abdominal Plan (TAP), standard post op pain control
- Keywords
- radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Abdominal Plan (TAP)Procedure or surgery
Also called lidocaine, ropivacaine
An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.
standard post op pain controlProcedure or surgery
Also called timed assessments for pain and medications
opiates
| Study group | Role | What they receive |
|---|---|---|
| TAP arm | Experimental | 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 Receives: Procedure: Transverse Abdominal Plan (TAP) |
| standard post operative pain control | Active comparator | 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. Receives: Procedure: standard post op pain control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Milligrams of Opiates
mean number of milligrams used postoperatively
Measured: 2, 6,12, 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Rendon, Nova Scotia Health Authority
- Investigators
- Ricardo A Rendon, MD, Principal investigator, Queen Elizabeth Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913068
- Sponsor's protocol ID
- version 2 July 13, 2009
- Acronym
- TAP
- Status last verified
- Sep 2021
- First submitted
- 1 Jun 2009
- Last updated
- 4 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Analgesia Using the Transverse Abdominal Plan (TAP) Block in Patients Undergoing a Radical Retropubic Prostatectomy (RRP)
- ClinicalTrials.gov ID
- NCT00913068
- Acronym / sponsor ID
- TAP / version 2 July 13, 2009
- Conditions
- Prostate Cancer
- Keywords
- radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 4 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP arm | Experimental | Procedure: Transverse Abdominal Plan (TAP)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 |
| standard post operative pain control | Active comparator | Procedure: standard post op pain controlOur 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- prostate cancer for radical prostatectomy
Key exclusion criteria (1 listed)
- chronic pain or opiate use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse Abdominal Plan (TAP)Also: lidocaine, ropivacaineAn injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field. | Procedure or surgery | TAP arm |
| standard post op pain controlAlso: timed assessments for pain and medicationsopiates | Procedure or surgery | standard post operative pain control |
Primary outcome
Total Milligrams of Opiates
Time frame: 2, 6,12, 24, 48 and 72 hours
mean number of milligrams used postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A Rendon, MD principal investigator
Queen Elizabeth Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse Abdominal Plan (TAP) in people with Prostate Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Milligrams of Opiates (time frame: 2, 6,12, 24, 48 and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.