Prostate Cancer
Conditions
Keywords
radical prostatectomy
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.
Interventions
PROCEDURETransverse Abdominal Plan (TAP)
An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.
PROCEDUREstandard post op pain control
opiates
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
* prostate cancer for radical prostatectomy
Exclusion criteria
* chronic pain or opiate use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Milligrams of Opiates | 2, 6,12, 24, 48 and 72 hours | mean number of milligrams used postoperatively |
Countries
Canada
Participant flow
Recruitment details
\<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.
Pre-assignment details
16 were excluded before starting the study due to chronic opiate use, or for requiring a secondary general anesthetic
Participants by arm
| Arm | Count |
|---|---|
| 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 | 56 |
| 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. | 54 |
| Total | 110 |
Baseline characteristics
| Characteristic | TAP Arm | Standard Post Operative Pain Control | Total |
|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 6.5 | 60.6 years STANDARD_DEVIATION 6.5 | 60.6 years STANDARD_DEVIATION 6.5 |
| Region of Enrollment Canada | 56 participants | 54 participants | 110 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 56 Participants | 54 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 54 |
| serious Total, serious adverse events | 0 / 56 | 0 / 54 |
Outcome results
Primary
Total Milligrams of Opiates
mean number of milligrams used postoperatively
Time frame: 2, 6,12, 24, 48 and 72 hours
Population: In order to achieve a power of 0.9 with a 20% change in pain scores, 40 patients were needed per arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAP Arm | Total Milligrams of Opiates | 5.15 mg | Standard Deviation 4.49 |
| Standard Post Operative Pain Control | Total Milligrams of Opiates | 2.52 mg | Standard Deviation 2.91 |
p-value: 0.0012Chi-squared