Trial Outcomes & Findings for Transverse Abdominis Plane (TAP) Block After Cesarean Delivery (NCT NCT01170702)
NCT ID: NCT01170702
Last Updated: 2021-12-08
Results Overview
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-24 hours after completion of the TAP block.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
24 hours
Results posted on
2021-12-08
Participant Flow
120 patients were randomized to one of four groups who received TAP blockade. Four patients subsequently were dropped from the study after randomization for pre-defined criteria. Substantive data was missing in one subject who was excluded from analysis. One patient received a morphine PCA instead of hydromorphone due to a drug shortage.
Participant milestones
| Measure |
Group 1
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
25
|
29
|
|
Overall Study
COMPLETED
|
33
|
30
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Overall Study
Exclusion criteria met after consent
|
1
|
2
|
0
|
2
|
Baseline Characteristics
1 subject did not respond for saline group previous cesarean delivery
Baseline characteristics by cohort
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
25 Participants
n=25 Participants
|
29 Participants
n=29 Participants
|
120 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=120 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
25 Participants
n=25 Participants
|
29 Participants
n=29 Participants
|
120 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=34 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=34 Participants
|
32 Participants
n=32 Participants
|
25 Participants
n=25 Participants
|
29 Participants
n=29 Participants
|
120 Participants
n=120 Participants
|
|
BMI (kg/m^2)
|
44.3 BMI (kg/m^2)
n=34 Participants
|
43.7 BMI (kg/m^2)
n=32 Participants
|
44.6 BMI (kg/m^2)
n=25 Participants
|
44.5 BMI (kg/m^2)
n=29 Participants
|
44.28 BMI (kg/m^2)
n=120 Participants
|
|
Estimated Gestational Age (EGA)
|
39 weeks
n=34 Participants
|
39 weeks
n=32 Participants
|
39 weeks
n=25 Participants
|
39 weeks
n=29 Participants
|
39 weeks
n=120 Participants
|
|
# previous Cesarean deliveries
No Cesarean Deliveries
|
12 Participants
n=33 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
9 Participants
n=30 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
12 Participants
n=25 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
9 Participants
n=27 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
42 Participants
n=115 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
|
# previous Cesarean deliveries
1 Cesarean Delivery
|
21 Participants
n=33 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
14 Participants
n=30 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
11 Participants
n=25 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
12 Participants
n=27 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
58 Participants
n=115 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
|
# previous Cesarean deliveries
> 1 Cesarean Deliveries
|
0 Participants
n=33 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
7 Participants
n=30 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
2 Participants
n=25 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
6 Participants
n=27 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
15 Participants
n=115 Participants • 1 subject did not respond for saline group previous cesarean delivery
|
|
Race/Ethnicity
Race of Participants : Caucasian
|
19 Participants
n=34 Participants
|
13 Participants
n=32 Participants
|
12 Participants
n=25 Participants
|
10 Participants
n=29 Participants
|
54 Participants
n=120 Participants
|
|
Race/Ethnicity
Race of Participants : African American
|
9 Participants
n=34 Participants
|
8 Participants
n=32 Participants
|
7 Participants
n=25 Participants
|
10 Participants
n=29 Participants
|
34 Participants
n=120 Participants
|
|
Race/Ethnicity
Race of Participants : Asian
|
1 Participants
n=34 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=29 Participants
|
3 Participants
n=120 Participants
|
|
Race/Ethnicity
Race of Participants : Hispanic
|
4 Participants
n=34 Participants
|
8 Participants
n=32 Participants
|
5 Participants
n=25 Participants
|
7 Participants
n=29 Participants
|
24 Participants
n=120 Participants
|
|
Race/Ethnicity
Other
|
1 Participants
n=34 Participants
|
2 Participants
n=32 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 24 hoursTotal dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-24 hours after completion of the TAP block.
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Morphine Equivalents 0-24 Hours (Mgs)
|
54 Morphine equivalents (mg)
Interval 37.0 to 70.0
|
38 Morphine equivalents (mg)
Interval 22.0 to 46.0
|
32 Morphine equivalents (mg)
Interval 18.0 to 54.0
|
45 Morphine equivalents (mg)
Interval 29.0 to 75.0
|
SECONDARY outcome
Timeframe: 24-72 hoursTotal dose of morphine equivalents (IV equivalent of morphine) taken by the participant 24-72 hours after completion of the TAP block.
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Morphine Equivalents 24-72 Hours (Mgs)
|
67 Morphine equivalents (mgs)
Interval 50.0 to 73.0
|
60 Morphine equivalents (mgs)
Interval 27.0 to 73.0
|
67 Morphine equivalents (mgs)
Interval 60.0 to 80.0
|
67 Morphine equivalents (mgs)
Interval 47.0 to 107.0
|
SECONDARY outcome
Timeframe: 72 hoursTotal dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-72 hours after completion of the TAP block.
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Morphine Equivalents Total (Mgs)
|
120 Morphine equivalents (mgs)
Interval 90.0 to 158.0
|
96 Morphine equivalents (mgs)
Interval 57.0 to 117.0
|
98 Morphine equivalents (mgs)
Interval 82.0 to 129.0
|
112 Morphine equivalents (mgs)
Interval 82.0 to 182.0
|
SECONDARY outcome
Timeframe: Elapsed time in minutesThe elapsed time in minutes of the first PCA (patient controlled analgesia) request in time (minutes) from the end of the TAP block.
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Time to First PCA Request
|
90 Minutes
Interval 40.0 to 112.0
|
118 Minutes
Interval 69.0 to 157.0
|
126 Minutes
Interval 75.0 to 182.0
|
83 Minutes
Interval 41.0 to 143.0
|
SECONDARY outcome
Timeframe: Request for first patient controlled analgesia then at 2,6,24,72 hours after initial PCA requestPain scores at rest ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the following hour time points, at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia).
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Pain Scores at Rest
At first PCA request
|
3 units on a scale
Interval 2.0 to 4.5
|
3 units on a scale
Interval 0.0 to 3.0
|
2 units on a scale
Interval 0.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
|
Pain Scores at Rest
2 hous after first PCA request
|
3 units on a scale
Interval 1.0 to 5.0
|
1 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 3.0
|
2 units on a scale
Interval 0.0 to 3.0
|
|
Pain Scores at Rest
6 hours after first PCA request
|
3 units on a scale
Interval 2.0 to 5.0
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 0.0 to 4.0
|
|
Pain Scores at Rest
24 hours after first PCA request
|
2 units on a scale
Interval 1.0 to 3.0
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 2.0
|
3 units on a scale
Interval 1.0 to 4.0
|
|
Pain Scores at Rest
72 hours after first PCA reqest
|
1 units on a scale
Interval 0.0 to 3.0
|
.5 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: First PCA request then at 2,6,24,72 hours after first PCA request.Pain scores with movement ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia).
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Pain Scores With Movement
At first PCA request
|
5 units on a scale
Interval 3.0 to 6.0
|
3.5 units on a scale
Interval 2.0 to 5.0
|
3.5 units on a scale
Interval 1.0 to 7.0
|
4 units on a scale
Interval 2.0 to 5.0
|
|
Pain Scores With Movement
2 hous after first PCA request
|
4 units on a scale
Interval 1.5 to 5.5
|
2 units on a scale
Interval 1.0 to 5.0
|
3 units on a scale
Interval 1.0 to 6.0
|
3 units on a scale
Interval 1.0 to 4.0
|
|
Pain Scores With Movement
6 hours after first PCA request
|
4 units on a scale
Interval 3.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
5 units on a scale
Interval 4.0 to 6.0
|
4 units on a scale
Interval 3.0 to 6.0
|
|
Pain Scores With Movement
24 hours after first PCA request
|
4 units on a scale
Interval 3.0 to 5.0
|
3 units on a scale
Interval 2.0 to 4.0
|
4 units on a scale
Interval 2.0 to 5.0
|
5 units on a scale
Interval 4.0 to 8.0
|
|
Pain Scores With Movement
72 hours after first PCA reqest
|
3.5 units on a scale
Interval 2.0 to 5.0
|
2 units on a scale
Interval 1.0 to 4.0
|
3 units on a scale
Interval 2.0 to 4.0
|
4 units on a scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 72 hoursPain burden at rest calculated as area under the pain score \* time (hr) curve 0-72 hours.
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Pain Burden at Rest
|
129 score on scale * (hr)
Interval 84.0 to 195.0
|
79 score on scale * (hr)
Interval 33.0 to 130.0
|
79 score on scale * (hr)
Interval 48.0 to 133.0
|
151 score on scale * (hr)
Interval 68.0 to 243.0
|
SECONDARY outcome
Timeframe: 72 hoursPain burden with movement calculated as area under the pain score \* time (hr) curve 0-72 hours.
Outcome measures
| Measure |
Group 1
n=34 Participants
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 Participants
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 Participants
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 Participants
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Pain Burden With Movement
|
265 pain score * time (hr) curve 72 hours
Interval 221.0 to 320.0
|
202 pain score * time (hr) curve 72 hours
Interval 120.0 to 278.0
|
233 pain score * time (hr) curve 72 hours
Interval 202.0 to 289.0
|
327 pain score * time (hr) curve 72 hours
Interval 217.0 to 417.0
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=34 participants at risk
TAP Block utilizing 15mL of 0.9% normal saline per side
0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 2
n=32 participants at risk
TAP Block utilizing 15ml of 0.2% ropivacaine per side
0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 3
n=25 participants at risk
TAP Block utilizing 15ml of 0.5% ropivacaine per side
0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
Group 4
n=29 participants at risk
TAP Block utilizing 15ml of 0.75% ropivacaine per side
0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea 2 hours after TAP
|
2.9%
1/34 • Number of events 1 • Two hours after TAP block
|
3.1%
1/32 • Number of events 1 • Two hours after TAP block
|
0.00%
0/25 • Two hours after TAP block
|
6.9%
2/29 • Number of events 2 • Two hours after TAP block
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.4%
10/34 • Number of events 10 • Two hours after TAP block
|
21.9%
7/32 • Number of events 7 • Two hours after TAP block
|
48.0%
12/25 • Number of events 12 • Two hours after TAP block
|
27.6%
8/29 • Number of events 8 • Two hours after TAP block
|
Additional Information
Edward Yaghmour
Northwestern University Feinberg School of Medicine
Phone: 312-695-0693
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place