Trial Outcomes & Findings for Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction (NCT NCT03700970)
NCT ID: NCT03700970
Last Updated: 2022-01-24
Results Overview
Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Postoperative day (POD) 1 to 7
Results posted on
2022-01-24
Participant Flow
Participant milestones
| Measure |
TAP Block With Liposomal Bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
TAP Block With Regular Bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 9.5 • n=30 Participants
|
52.2 years
STANDARD_DEVIATION 9.8 • n=30 Participants
|
52.6 years
STANDARD_DEVIATION 9.6 • n=60 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index (BMI)
|
29.6 kg/m^2
STANDARD_DEVIATION 5.3 • n=30 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 4.3 • n=30 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 4.8 • n=60 Participants
|
|
Smoker
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Diabetic
|
8 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
|
Hypertension (HTN)
|
9 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Hypercoagulable states
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
History of hormonal therapy (HT)
None
|
12 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
29 Participants
n=60 Participants
|
|
History of hormonal therapy (HT)
Prior HT
|
5 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
|
History of hormonal therapy (HT)
Current HT
|
13 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
23 Participants
n=60 Participants
|
|
Prior radiation
|
6 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
16 Participants
n=60 Participants
|
|
Immunosuppressive medications
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Prior chemotherapy
|
10 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Deep Inferior Epigastric Artery Perforator (DIEP) Laterality
Unilateral DIEP
|
9 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
16 Participants
n=60 Participants
|
|
Deep Inferior Epigastric Artery Perforator (DIEP) Laterality
Bilateral DIEP
|
21 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
44 Participants
n=60 Participants
|
|
DIEP timing
Immediate DIEP
|
5 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
DIEP timing
Delayed DIEP
|
25 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
49 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Postoperative day (POD) 1 to 7Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 1
|
19.8 mg morphine equivalents
Standard Deviation 18.8
|
23.6 mg morphine equivalents
Standard Deviation 17.5
|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 2
|
20.7 mg morphine equivalents
Standard Deviation 20.5
|
25.2 mg morphine equivalents
Standard Deviation 23.5
|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 3
|
12.2 mg morphine equivalents
Standard Deviation 15.3
|
12.8 mg morphine equivalents
Standard Deviation 11.7
|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 4
|
8.2 mg morphine equivalents
Standard Deviation 8.7
|
8.8 mg morphine equivalents
Standard Deviation 9.3
|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 5
|
7.33 mg morphine equivalents
Standard Deviation 8.48
|
6.52 mg morphine equivalents
Standard Deviation 8.51
|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 6
|
5.1 mg morphine equivalents
Standard Deviation 7.0
|
6.8 mg morphine equivalents
Standard Deviation 7.7
|
|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
POD 7
|
3.8 mg morphine equivalents
Standard Deviation 5.9
|
4.9 mg morphine equivalents
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Post operative day (POD) 1 to 7Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Pain Measure
POD 1
|
2.43 score on a scale
Standard Deviation 1.98
|
2.93 score on a scale
Standard Deviation 2.80
|
|
Pain Measure
POD 2
|
2 score on a scale
Standard Deviation 1.7
|
3.1 score on a scale
Standard Deviation 3
|
|
Pain Measure
POD 3
|
2.9 score on a scale
Standard Deviation 2.3
|
3.1 score on a scale
Standard Deviation 2.5
|
|
Pain Measure
POD 4
|
2.9 score on a scale
Standard Deviation 2.2
|
3.1 score on a scale
Standard Deviation 2.7
|
|
Pain Measure
POD 5
|
2.6 score on a scale
Standard Deviation 2.2
|
3.1 score on a scale
Standard Deviation 2.6
|
|
Pain Measure
POD 6
|
2.3 score on a scale
Standard Deviation 2.1
|
3.2 score on a scale
Standard Deviation 2.7
|
|
Pain Measure
POD 7
|
2.3 score on a scale
Standard Deviation 2.3
|
2.8 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 0-29.8 hours post operationTime from end of surgery to time of first opioid intake measured in hours
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Time to First Opiate Use
|
12.4 hours
Standard Deviation 17.4
|
8.2 hours
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 1 to 4 days post operationMean time in days at which patients had a return of bowel movement post op
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Time to Return of Bowel Function
|
2.62 days
Standard Deviation 0.97
|
2.58 days
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 1 to 4 daysLength of hospital stay post operatively
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Length of Stay
|
2.43 DAYS
Standard Deviation 0.77
|
2.23 DAYS
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 1 day post opTime to first ambulate post op (in days)
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Ambulation
|
1 days
Standard Deviation 0
|
1 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Post op day 1 to 7The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 1
|
2630 milligrams
Standard Deviation 803
|
2840 milligrams
Standard Deviation 503
|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 2
|
2937 milligrams
Standard Deviation 972
|
2868 milligrams
Standard Deviation 799
|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 3
|
2160 milligrams
Standard Deviation 1334
|
1945 milligrams
Standard Deviation 1342
|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 4
|
1937 milligrams
Standard Deviation 1239
|
1722 milligrams
Standard Deviation 116
|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 5
|
1757 milligrams
Standard Deviation 1159
|
1755 milligrams
Standard Deviation 1130
|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 6
|
1903 milligrams
Standard Deviation 1179
|
1755 milligrams
Standard Deviation 1067
|
|
Non-narcotic Pain Medication Intake: Acetaminophen
POD 7
|
1887 milligrams
Standard Deviation 1174
|
1588 milligrams
Standard Deviation 1171
|
SECONDARY outcome
Timeframe: Post op day 1 to 7The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 1
|
0.5 milligrams
Standard Deviation 1.5
|
1.2 milligrams
Standard Deviation 5.5
|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 2
|
2 milligrams
Standard Deviation 4.3
|
1.2 milligrams
Standard Deviation 4.1
|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 3
|
2.5 milligrams
Standard Deviation 4.9
|
1.5 milligrams
Standard Deviation 4.4
|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 4
|
3.7 milligrams
Standard Deviation 8.1
|
1.7 milligrams
Standard Deviation 4.8
|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 5
|
3.7 milligrams
Standard Deviation 7.2
|
1.8 milligrams
Standard Deviation 4.8
|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 6
|
4 milligrams
Standard Deviation 8.3
|
1.8 milligrams
Standard Deviation 4.8
|
|
Non Narcotic Pain Medication Intake: Cyclobenzaprine
POD 7
|
3 milligrams
Standard Deviation 6.8
|
2.2 milligrams
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Post op day 1 to 7The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 1
|
730 milligrams
Standard Deviation 315
|
750 milligrams
Standard Deviation 298
|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 2
|
807 milligrams
Standard Deviation 358
|
813 milligrams
Standard Deviation 356
|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 3
|
680 milligrams
Standard Deviation 489
|
577 milligrams
Standard Deviation 378
|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 4
|
603 milligrams
Standard Deviation 454
|
517 milligrams
Standard Deviation 371
|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 5
|
537 milligrams
Standard Deviation 451
|
583 milligrams
Standard Deviation 397
|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 6
|
503 milligrams
Standard Deviation 453
|
560 milligrams
Standard Deviation 443
|
|
Non Narcotic Pain Medication Intake: Gabapentin
POD 7
|
457 milligrams
Standard Deviation 449
|
527 milligrams
Standard Deviation 445
|
SECONDARY outcome
Timeframe: post op day 1 to 7The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 1
|
200 milligrams
Standard Deviation 144
|
187 milligrams
Standard Deviation 138
|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 2
|
193 milligrams
Standard Deviation 146
|
203 milligrams
Standard Deviation 119
|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 3
|
67 milligrams
Standard Deviation 132
|
60 milligrams
Standard Deviation 113
|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 4
|
20 milligrams
Standard Deviation 61
|
0 milligrams
Standard Deviation 0
|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 5
|
20 milligrams
Standard Deviation 61
|
0 milligrams
Standard Deviation 0
|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 6
|
13 milligrams
Standard Deviation 51
|
0 milligrams
Standard Deviation 0
|
|
Non Narcotic Pain Medication Intake: Celebrex
POD 7
|
13 milligrams
Standard Deviation 51
|
0 milligrams
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Post op day 1 to 7The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization
Outcome measures
| Measure |
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
n=30 Participants
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 1
|
1.3 milligrams
Standard Deviation 2.6
|
2.3 milligrams
Standard Deviation 3.3
|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 2
|
0.4 milligrams
Standard Deviation 1.6
|
0.4 milligrams
Standard Deviation 1.2
|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 3
|
0.27 milligrams
Standard Deviation 1.46
|
0.27 milligrams
Standard Deviation 1.01
|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 4
|
0 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 5
|
0 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 6
|
0 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
|
Non Narcotic Pain Medication Intake: Ondansetron
POD 7
|
0 milligrams
Standard Deviation 0
|
0 milligrams
Standard Deviation 0
|
Adverse Events
TAP Block With Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAP Block With Regular Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAP Block With Liposomal Bupivacaine
n=30 participants at risk
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
|
TAP Block With Regular Bupivacaine
n=30 participants at risk
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bupivacaine toxicity
|
0.00%
0/30 • 6 months
|
0.00%
0/30 • 6 months
|
|
Blood and lymphatic system disorders
Narcotic complication
|
0.00%
0/30 • 6 months
|
0.00%
0/30 • 6 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/30 • 6 months
|
0.00%
0/30 • 6 months
|
|
Skin and subcutaneous tissue disorders
Flap loss
|
0.00%
0/30 • 6 months
|
0.00%
0/30 • 6 months
|
Additional Information
Dr. Galen Perdikis
Vanderbilt university medical center
Phone: +1 (615) 936-0198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place