Trial Outcomes & Findings for Postoperative Pain Control for Prostatectomy (NCT NCT00913068)
NCT ID: NCT00913068
Last Updated: 2021-10-04
Results Overview
mean number of milligrams used postoperatively
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
2, 6,12, 24, 48 and 72 hours
Results posted on
2021-10-04
Participant Flow
\<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.
16 were excluded before starting the study due to chronic opiate use, or for requiring a secondary general anesthetic
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
|
Overall Study
COMPLETED
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postoperative Pain Control for Prostatectomy
Baseline characteristics by cohort
| Measure |
TAP Arm
n=56 Participants
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
|
Standard Post Operative Pain Control
n=54 Participants
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.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
56 participants
n=5 Participants
|
54 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2, 6,12, 24, 48 and 72 hoursPopulation: In order to achieve a power of 0.9 with a 20% change in pain scores, 40 patients were needed per arm
mean number of milligrams used postoperatively
Outcome measures
| Measure |
TAP Arm
n=48 Participants
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
|
Standard Post Operative Pain Control
n=46 Participants
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.
|
|---|---|---|
|
Total Milligrams of Opiates
|
5.15 mg
Standard Deviation 4.49
|
2.52 mg
Standard Deviation 2.91
|
Adverse Events
TAP Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Post Operative Pain Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place