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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transverse Abdominal Plan (TAP) | Procedure | An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Milligrams of Opiates | mean number of milligrams used postoperatively | 2, 6,12, 24, 48 and 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo A Rendon, MD | Queen Elizabeth Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
16 were excluded before starting the study due to chronic opiate use, or for requiring a secondary general anesthetic
<75, open radical prostatectomy, December 2010 - September 2011. Ketorolac, paralytics, fentanyl, propofol, sevoflurane or isofluroane use was at discretion of anesthetist. Patients requiring spinal or epidural anesthetics, history of chronic pain, chronic opiate use and and need for second general anesthetic within the first 24 h were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAP Arm | in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm |
| FG001 | Standard Post Operative Pain Control | Injection of saline. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAP Arm | in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm |
| BG001 | Standard Post Operative Pain Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Milligrams of Opiates | mean number of milligrams used postoperatively | In order to achieve a power of 0.9 with a 20% change in pain scores, 40 patients were needed per arm | Posted | Mean | Standard Deviation | mg | 2, 6,12, 24, 48 and 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAP Arm | in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ricardo A. Rendon | Capital District Health Authority | 9024736604 | rrendon@dal.ca |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077212 | Ropivacaine |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| standard post op pain control | Procedure | opiates |
|
|
Injection of saline. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Standard Post Operative Pain Control | Injection of saline. 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. | 0 | 54 | 0 | 54 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |