Pain Control
Conditions
Brief summary
TAP Block done with 2 different concentrations of bupivacaine and placebo
Detailed description
TAP Block was done using 2 different concentrations of bupivacaine (0.5% and 0.25%) and placebo and the post operative sedation was measured in each arm and compared together.
Interventions
PROCEDURETAP 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.
PROCEDURETAP 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.
PROCEDURETAP 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.
Sponsors
New York Presbyterian Brooklyn Methodist Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The randomization sheet was given to someone who is not involved in the study, also the person who prepare the medicine is not involved in the study.
Intervention model description
Arm 1: Bupivacaine 05%, arm 2: Bupivacaine 0.25%, and arm 3: placebo (Normal saline)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Healthy pregnant women
Exclusion criteria
* Allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 0-24 hours | The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | TAP Using Bupivacaine 0.25% | Placebo | TAP Using Bupivacaine 0.5% | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 34.5 years | 32.5 years | 33 years | 33 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment North America | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours
Time frame: 0-24 hours
Population: Number of PCA bolus used within 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAP Using Bupivacaine 0.5% | 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 |
| TAP Using Bupivacaine 0.25% | 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. | 8.95 PCA bolus | Standard Error 1.756 |
| Placebo | 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. | 17.65 PCA bolus | Standard Error 2.893 |