Trial Outcomes & Findings for Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies (NCT NCT01575028)
NCT ID: NCT01575028
Last Updated: 2015-08-24
Results Overview
Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
12 hours post-operatively
Results posted on
2015-08-24
Participant Flow
Participant milestones
| Measure |
Local Anesthetic Infiltration Injection
Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.
|
Transversus Abdominis Plane (TAP) Block
Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Local Anesthetic Infiltration Injection
Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.
|
Transversus Abdominis Plane (TAP) Block
Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
Baseline characteristics by cohort
| Measure |
Local Anesthetic Infiltration Injection
n=2 Participants
Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.
Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.
|
Transversus Abdominis Plane (TAP) Block
n=1 Participants
Patients will receive a transversus abdominis plane (TAP) block.
Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
13.425 years
STANDARD_DEVIATION 4.871965722 • n=93 Participants
|
7.36 years
STANDARD_DEVIATION 0 • n=4 Participants
|
11.40 years
STANDARD_DEVIATION 4.91 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 hours post-operativelyPopulation: Due to changes in surgical technique \& protocols by the general surgeons, we were only able to recruit 3 study subjects and the study was terminated. No analysis was performed.
Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.
Outcome measures
Outcome data not reported
Adverse Events
Local Anesthetic Infiltration Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transversus Abdominis Plane (TAP) Block
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