Trial Outcomes & Findings for Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery (NCT NCT03856788)
NCT ID: NCT03856788
Last Updated: 2022-10-17
Results Overview
Amount of intravenous (IV) opioid consumption within 24-hour period
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
24 Hours postoperative
Results posted on
2022-10-17
Participant Flow
Participant milestones
| Measure |
Saline
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal Transversus Abdominis Plane (TAP) block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline
|
Bupivacaine
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Saline
n=21 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline
|
Bupivacaine
n=19 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=21 Participants
|
36 years
n=19 Participants
|
36.5 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=21 Participants
|
16 Participants
n=19 Participants
|
25 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=21 Participants
|
3 Participants
n=19 Participants
|
15 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 24 Hours postoperativeAmount of intravenous (IV) opioid consumption within 24-hour period
Outcome measures
| Measure |
Saline
n=21 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline
|
Bupivacaine
n=19 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine
|
|---|---|---|
|
Amount of 24 Hour Opioid Consumption
|
44.7 morphine milligram equivalents
Interval 33.4 to 59.8
|
38.7 morphine milligram equivalents
Interval 24.0 to 49.0
|
SECONDARY outcome
Timeframe: average 2-3 HoursAmount of intravenous opioid consumption during the surgery
Outcome measures
| Measure |
Saline
n=21 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline
|
Bupivacaine
n=19 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine
|
|---|---|---|
|
Amount of Intraoperative IV Opioid Consumption
|
35 morphine milligram equivalents
Interval 32.5 to 40.0
|
32.5 morphine milligram equivalents
Interval 25.0 to 447.5
|
SECONDARY outcome
Timeframe: 24 Hours postoperativePatients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery.
Outcome measures
| Measure |
Saline
n=21 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline
|
Bupivacaine
n=19 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine
|
|---|---|---|
|
Number of Participants Asked Area of Pain on the Body After Surgery
none
|
3 Participants
|
7 Participants
|
|
Number of Participants Asked Area of Pain on the Body After Surgery
diffuse
|
7 Participants
|
1 Participants
|
|
Number of Participants Asked Area of Pain on the Body After Surgery
RUQ
|
3 Participants
|
3 Participants
|
|
Number of Participants Asked Area of Pain on the Body After Surgery
LUQ
|
1 Participants
|
2 Participants
|
|
Number of Participants Asked Area of Pain on the Body After Surgery
RLQ
|
0 Participants
|
0 Participants
|
|
Number of Participants Asked Area of Pain on the Body After Surgery
LLQ
|
0 Participants
|
0 Participants
|
|
Number of Participants Asked Area of Pain on the Body After Surgery
epigastric
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 Hours postoperativeNumber of participants who answered yes to having presence of nausea after surgery
Outcome measures
| Measure |
Saline
n=21 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline
|
Bupivacaine
n=19 Participants
Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine
|
|---|---|---|
|
Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery
|
16 Participants
|
14 Participants
|
Adverse Events
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Adverse event data not reported
Additional Information
Christina Jeng, MD, FASA
Icahn School of Medicine at Mount Sinai
Phone: 212) 241-6426
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place