Trial Outcomes & Findings for The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study (NCT NCT01075087)
NCT ID: NCT01075087
Last Updated: 2014-06-26
Results Overview
Quality of Recovery 40 Score at 24 hours postoperative.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
24 hours post operatively
Results posted on
2014-06-26
Participant Flow
Subjects were enrolled consecutively from 03/2010 through 07/2012 in the pre operative area of the hospital.
26 were assessed for eligibility. 7 were excluded ( 4 did not meet inclusion criteria and 3 refused to participate).
Participant milestones
| Measure |
Placebo
(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline.
|
Active Comparator
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Pre-Operative Transversus Abdominis Plane (TAP) Block in the Post Operative Opioid Consumption in Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery: A Prospective,Randomized, Blinded Study
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline.
|
Active Comparator
n=10 Participants
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
47 years
n=107 Participants
|
48 years
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours post operativelyQuality of Recovery 40 Score at 24 hours postoperative.
Outcome measures
| Measure |
Placebo
n=9 Participants
(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline.
|
Active Comparator
n=10 Participants
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
|
|---|---|---|
|
Quality of Recovery 40 Score
|
170 units on scale 40 (low) - 200 (high)
Interval 160.0 to 175.0
|
175.5 units on scale 40 (low) - 200 (high)
Interval 170.0 to 189.0
|
SECONDARY outcome
Timeframe: 24 hours24 Hour total opioid consumption translated into IV morphine equivalents.
Outcome measures
| Measure |
Placebo
n=9 Participants
(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline.
|
Active Comparator
n=10 Participants
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
|
|---|---|---|
|
24 Hour Total Opioid Consumption.
|
13 miligram IV morphine equivalents
Interval 7.0 to 21.5
|
7.5 miligram IV morphine equivalents
Interval 2.5 to 11.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Active Comparator
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
(control group) will receive sterile normal saline in the block
Placebo: Bilateral TAP block using sterile normal saline.
|
Active Comparator
n=10 participants at risk
(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place