Trial Outcomes & Findings for Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter (NCT NCT04787367)
NCT ID: NCT04787367
Last Updated: 2026-07-02
Results Overview
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Post-operatively at 0 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours
Results posted on
2026-07-02
Participant Flow
Participant milestones
| Measure |
Early-operative TAP Block
The TAP block will be administered after the placement of the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
Late-operative TAP Block
The TAP block will be administered at the completion of the case just before removing the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter
Baseline characteristics by cohort
| Measure |
Early-operative TAP Block
n=100 Participants
The TAP block will be administered after the placement of the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
Late-operative TAP Block
n=100 Participants
The TAP block will be administered at the completion of the case just before removing the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Weight
|
116.9 weight in "kg"
STANDARD_DEVIATION 21 • n=20 Participants
|
122.0 weight in "kg"
STANDARD_DEVIATION 24 • n=20 Participants
|
119.5 weight in "kg"
STANDARD_DEVIATION 23 • n=40 Participants
|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 13 • n=20 Participants
|
43.8 years
STANDARD_DEVIATION 11 • n=20 Participants
|
43.4 years
STANDARD_DEVIATION 12 • n=40 Participants
|
|
Sex/Gender, Customized
Female
|
89.0 Participants
n=20 Participants
|
90.0 Participants
n=20 Participants
|
179 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Male
|
11.0 Participants
n=20 Participants
|
10.0 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
61.0 Participants
n=20 Participants
|
59.0 Participants
n=20 Participants
|
120 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
African American
|
37.0 Participants
n=20 Participants
|
35.0 Participants
n=20 Participants
|
72 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1.0 Participants
n=20 Participants
|
4.0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
1.0 Participants
n=20 Participants
|
2.0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=20 Participants
|
100 participants
n=20 Participants
|
200 participants
n=40 Participants
|
|
BMI
|
45.6 kg/m^2
STANDARD_DEVIATION 7 • n=20 Participants
|
46.5 kg/m^2
STANDARD_DEVIATION 7 • n=20 Participants
|
46.0 kg/m^2
STANDARD_DEVIATION 7 • n=40 Participants
|
|
Hypertension
Yes
|
50.0 Participants
n=20 Participants
|
49.0 Participants
n=20 Participants
|
99 Participants
n=40 Participants
|
|
Hypertension
No
|
50.0 Participants
n=20 Participants
|
51.0 Participants
n=20 Participants
|
101 Participants
n=40 Participants
|
|
Hyperlipidemia
Yes
|
48.0 Participants
n=20 Participants
|
48.0 Participants
n=20 Participants
|
96 Participants
n=40 Participants
|
|
Hyperlipidemia
No
|
52.0 Participants
n=20 Participants
|
52.0 Participants
n=20 Participants
|
104 Participants
n=40 Participants
|
|
Obstructive Sleep Apnea
Yes
|
43.0 Participants
n=20 Participants
|
39.0 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
|
Obstructive Sleep Apnea
No
|
57.0 Participants
n=20 Participants
|
61.0 Participants
n=20 Participants
|
118 Participants
n=40 Participants
|
|
Arthritis
Yes
|
29.0 Participants
n=20 Participants
|
38.0 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Arthritis
No
|
71.0 Participants
n=20 Participants
|
62.0 Participants
n=20 Participants
|
133 Participants
n=40 Participants
|
|
Degenerative Disc Disease
Yes
|
8.0 Participants
n=20 Participants
|
9.0 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Degenerative Disc Disease
No
|
92.0 Participants
n=20 Participants
|
91.0 Participants
n=20 Participants
|
183 Participants
n=40 Participants
|
|
Hiatal Hernia Repair
Yes
|
18.0 Participants
n=20 Participants
|
20.0 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Hiatal Hernia Repair
No
|
82.0 Participants
n=20 Participants
|
80.0 Participants
n=20 Participants
|
162 Participants
n=40 Participants
|
|
Type II Diabetes
Yes
|
39.0 Participants
n=20 Participants
|
25.0 Participants
n=20 Participants
|
64 Participants
n=40 Participants
|
|
Type II Diabetes
No
|
61.0 Participants
n=20 Participants
|
75.0 Participants
n=20 Participants
|
136 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Post-operatively at 0 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hoursUsing the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
Outcome measures
| Measure |
Early-operative TAP Block
n=100 Participants
The TAP block will be administered after the placement of the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
Late-operative TAP Block
n=100 Participants
The TAP block will be administered at the completion of the case just before removing the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
|---|---|---|
|
Pain Scores Between Early and Late Groups
4 hours
|
3.78 score on a scale
Standard Deviation 31.0
|
3.20 score on a scale
Standard Deviation 2.99
|
|
Pain Scores Between Early and Late Groups
16 hours
|
2.08 score on a scale
Standard Deviation 2.68
|
2.12 score on a scale
Standard Deviation 2.63
|
|
Pain Scores Between Early and Late Groups
20 hours
|
2.22 score on a scale
Standard Deviation 2.63
|
1.93 score on a scale
Standard Deviation 2.37
|
|
Pain Scores Between Early and Late Groups
24 hours
|
1.91 score on a scale
Standard Deviation 2.49
|
1.35 score on a scale
Standard Deviation 2.11
|
|
Pain Scores Between Early and Late Groups
0 hours
|
3.16 score on a scale
Standard Deviation 3.15
|
3.23 score on a scale
Standard Deviation 3.11
|
|
Pain Scores Between Early and Late Groups
8 hours
|
2.90 score on a scale
Standard Deviation 2.83
|
2.75 score on a scale
Standard Deviation 2.76
|
|
Pain Scores Between Early and Late Groups
12 hours
|
2.54 score on a scale
Standard Deviation 2.74
|
2.38 score on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: PACU until time of discharge up to 30 daysAmount of opioid medication given to the patients.
Outcome measures
| Measure |
Early-operative TAP Block
n=100 Participants
The TAP block will be administered after the placement of the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
Late-operative TAP Block
n=100 Participants
The TAP block will be administered at the completion of the case just before removing the camera port.
TAP block: An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
|
|---|---|---|
|
Analgesic Utilization in Early and Late Groups
Surgical Unit Opioids · Yes
|
43.0 Participants
|
34.0 Participants
|
|
Analgesic Utilization in Early and Late Groups
Surgical Unit Opioids · No
|
57.0 Participants
|
66.0 Participants
|
|
Analgesic Utilization in Early and Late Groups
Methocarbamol · Yes
|
76.0 Participants
|
81.0 Participants
|
|
Analgesic Utilization in Early and Late Groups
Methocarbamol · No
|
24.0 Participants
|
19.0 Participants
|
|
Analgesic Utilization in Early and Late Groups
PACU Opioids · Yes
|
26.0 Participants
|
32.0 Participants
|
|
Analgesic Utilization in Early and Late Groups
PACU Opioids · No
|
74.0 Participants
|
68.0 Participants
|
Adverse Events
Early-operative TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late-operative TAP 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place