Trial Outcomes & Findings for Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair? (NCT NCT02007096)
NCT ID: NCT02007096
Last Updated: 2018-01-19
Results Overview
Amount of opioids used by patients at certain time points.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
up to 24 hours
Results posted on
2018-01-19
Participant Flow
Participants recruited from the Department of Surgery at The Mount Sinai Hospital between November 2012 and October 2014.
Participant milestones
| Measure |
Transabdominal Plane Block
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
Non Transabdominal Plane Block: Saline injection
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
64
|
|
Overall Study
COMPLETED
|
52
|
48
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
Transabdominal Plane Block
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
Non Transabdominal Plane Block: Saline injection
|
|---|---|---|
|
Overall Study
medication not available
|
2
|
0
|
|
Overall Study
did not inject saline
|
0
|
3
|
|
Overall Study
did not follow postoperative protocol
|
8
|
11
|
|
Overall Study
converted to open surgery
|
1
|
1
|
|
Overall Study
no mesh placed
|
0
|
1
|
Baseline Characteristics
Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?
Baseline characteristics by cohort
| Measure |
Transabdominal Plane Block
n=52 Participants
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
n=48 Participants
Non Transabdominal Plane Block: Saline injection
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.67 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
53.81 years
STANDARD_DEVIATION 13.45 • n=7 Participants
|
53.22 years
STANDARD_DEVIATION 13.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
BMI
|
30.91 kg/m^2
STANDARD_DEVIATION 5.45 • n=5 Participants
|
31.16 kg/m^2
STANDARD_DEVIATION 7.00 • n=7 Participants
|
31.03 kg/m^2
STANDARD_DEVIATION 6.21 • n=5 Participants
|
|
ASA class
1
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
ASA class
2
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
ASA class
3
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
ASA class
4
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hypertension
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Diabetes
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Hyperlipidemia
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Coronary artery disease
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
GERD
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Smoker
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Previous abdominal surgery
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Hernia defect size
|
38.46 cm^2
STANDARD_DEVIATION 42.26 • n=5 Participants
|
39.84 cm^2
STANDARD_DEVIATION 61.27 • n=7 Participants
|
39.12 cm^2
STANDARD_DEVIATION 51.99 • n=5 Participants
|
|
Location of hernia defect
Epigastric
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Location of hernia defect
Umbilical
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Location of hernia defect
Infraumbilical
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Location of hernia defect
Lateral
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
LOS
<2 days
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
LOS
≥2 days
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 hoursAmount of opioids used by patients at certain time points.
Outcome measures
| Measure |
Transabdominal Plane Block
n=52 Participants
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
n=48 Participants
Non Transabdominal Plane Block: Saline injection
|
|---|---|---|
|
Post-operative Opioid Use
at 6 hours
|
10.59 mg
Standard Deviation 0
|
15.62 mg
Standard Deviation 0
|
|
Post-operative Opioid Use
at 12 hours
|
16.09 mg
Standard Deviation 0
|
32.24 mg
Standard Deviation 0
|
|
Post-operative Opioid Use
at 18 hours
|
20.70 mg
Standard Deviation 0
|
39.37 mg
Standard Deviation 0
|
|
Post-operative Opioid Use
at 24 hours
|
25.64 mg
Standard Deviation 0
|
42.56 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 hour postoperativelyPost-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."
Outcome measures
| Measure |
Transabdominal Plane Block
n=52 Participants
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
n=48 Participants
Non Transabdominal Plane Block: Saline injection
|
|---|---|---|
|
Pain Score
pain scores at rest
|
5.19 units on a scale
Standard Deviation 0.39
|
6.46 units on a scale
Standard Deviation 0.38
|
|
Pain Score
pain scores with movement
|
6.15 units on a scale
Standard Deviation 0.42
|
7.73 units on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Procedure begin time to procedure end timeTotal number of minutes for the procedure, not including anesthesia time.
Outcome measures
| Measure |
Transabdominal Plane Block
n=52 Participants
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
n=48 Participants
Non Transabdominal Plane Block: Saline injection
|
|---|---|---|
|
Operating Procedure Time
|
97.41 min
Standard Deviation 30.22
|
98.81 min
Standard Deviation 37.51
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPost-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being "no pain" and 10 being "the most pain you have ever experienced."
Outcome measures
| Measure |
Transabdominal Plane Block
n=52 Participants
Transabdominal Plane Block with 0.25% bupivacaine
|
Non Transabdominal Plane Block
n=48 Participants
Non Transabdominal Plane Block: Saline injection
|
|---|---|---|
|
Pain Score
pain scores at rest
|
4.60 units on a scale
Standard Deviation 0.39
|
4.52 units on a scale
Standard Deviation 0.31
|
|
Pain Score
pain scores with movement
|
6.75 units on a scale
Standard Deviation 0.38
|
6.98 units on a scale
Standard Deviation 0.40
|
Adverse Events
Transabdominal Plane Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non Transabdominal Plane 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
Dr. Celia M Divino
Division of General Surgery, Department of Surgery, The Mount Sinai Medical Center
Phone: 212-241-5499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place