Trial Outcomes & Findings for Single-shot TAP Block vs Continuous TAP Block (NCT NCT02475031)
NCT ID: NCT02475031
Last Updated: 2020-08-04
Results Overview
The primary endpoint of this study will be narcotic requirement at 48 hours
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
48 hours
Results posted on
2020-08-04
Participant Flow
Participant milestones
| Measure |
Placebo Group (TAP-S)
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-shot TAP Block vs Continuous TAP Block
Baseline characteristics by cohort
| Measure |
Placebo Group (TAP-S)
n=35 Participants
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
n=35 Participants
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.26 years
STANDARD_DEVIATION 12.07 • n=5 Participants
|
39.91 years
STANDARD_DEVIATION 10.21 • n=7 Participants
|
41.09 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursThe primary endpoint of this study will be narcotic requirement at 48 hours
Outcome measures
| Measure |
Placebo Group (TAP-S)
n=35 Participants
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
n=35 Participants
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
|---|---|---|
|
Total Narcotic Usage at 48 Hours
|
2.44 mg
Standard Error 0.43
|
2.88 mg
Standard Error 0.59
|
SECONDARY outcome
Timeframe: up to 60 hoursAll narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.
Outcome measures
| Measure |
Placebo Group (TAP-S)
n=35 Participants
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
n=35 Participants
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
|---|---|---|
|
Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours
|
14.31 mg
Standard Error 2.12
|
14.40 mg
Standard Error 1.73
|
SECONDARY outcome
Timeframe: up to 60 hoursPost- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.
Outcome measures
| Measure |
Placebo Group (TAP-S)
n=35 Participants
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
n=35 Participants
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
|---|---|---|
|
Average Pain Scores
|
5.31 units on a scale
Standard Error 0.34
|
5.06 units on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: up to 48 hoursPost-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.
Outcome measures
| Measure |
Placebo Group (TAP-S)
n=35 Participants
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
n=35 Participants
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
|---|---|---|
|
Nausea Scores at 48 Hours
|
0.34 units on a scale
Standard Error 0.12
|
0.34 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 48 hoursPost-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.
Outcome measures
| Measure |
Placebo Group (TAP-S)
n=35 Participants
(TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
Active Group (TAP-C)
n=35 Participants
(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block
ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case
Oxycodone/Acetaminophen
|
|---|---|---|
|
Sedation Scores at 48 Hours
|
0.2 units on a scale
Standard Error 0.08
|
0.06 units on a scale
Standard Error 0.04
|
Adverse Events
Placebo Group (TAP-S)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Group (TAP-C)
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
Dr. Yar Yeap
Indiana University School of Medicine - Anesthesia Division
Phone: 317-274-0275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place