Trial Outcomes & Findings for Efficacy of TAP Block in Cesarean Section Patients (NCT NCT03493828)
NCT ID: NCT03493828
Last Updated: 2018-11-13
Results Overview
The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
0-24 hours
Results posted on
2018-11-13
Participant Flow
Participant milestones
| Measure |
TAP Using Bupivacaine 0.5%
TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
TAP Using Bupivacaine 0.25%
TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
Placebo
TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
Total
n=60 Participants
Total of all reporting groups
|
TAP Using Bupivacaine 0.5%
n=20 Participants
TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
TAP Using Bupivacaine 0.25%
n=20 Participants
TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
32.5 years
n=20 Participants
|
33 years
n=60 Participants
|
33 years
n=20 Participants
|
34.5 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
—
|
—
|
|
Region of Enrollment
North America
|
20 participants
n=20 Participants
|
60 participants
n=60 Participants
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 0-24 hoursPopulation: Number of PCA bolus used within 24 hours
The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours
Outcome measures
| Measure |
TAP Using Bupivacaine 0.5%
n=20 Participants
TAP block using Bupivacaine 0.5%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
TAP Using Bupivacaine 0.25%
n=20 Participants
TAP block using Bupivacaine 0.25%: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
Placebo
n=20 Participants
TAP block using Normal Saline: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
|
|---|---|---|---|
|
Effect of Transversus Abdominis Plane (TAP) Block Using Either 0.5% or 0.25% Bupivacaine on Analgesia for Cesarean Section Patients When Compared to Placebo.
|
9.45 PCA bolus
Standard Error 1.292
|
8.95 PCA bolus
Standard Error 1.756
|
17.65 PCA bolus
Standard Error 2.893
|
Adverse Events
TAP Using Bupivacaine 0.5%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAP Using Bupivacaine 0.25%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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