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Trial Outcomes & Findings for Regional TAP Block for Bariatric Patients (NCT NCT04051684)

NCT ID: NCT04051684

Last Updated: 2019-12-03

Results Overview

The amounts of opioids used by the patient will be collected by a person blinded to the allocation group

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

24 hour after surgery

Results posted on

2019-12-03

Participant Flow

Participant milestones

Participant milestones
Measure
TAP, Bupivacaine
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No Intervention
General anesthesia
Overall Study
STARTED
12
11
Overall Study
COMPLETED
12
11
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regional TAP Block for Bariatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TAP, Bupivacaine
n=12 Participants
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No Intervention
n=11 Participants
General anesthesia
Total
n=23 Participants
Total of all reporting groups
Age, Continuous
43.5 years
n=5 Participants
43 years
n=7 Participants
43.5 years
n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
10 Participants
n=7 Participants
21 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
11 participants
n=7 Participants
23 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 hour after surgery

The amounts of opioids used by the patient will be collected by a person blinded to the allocation group

Outcome measures

Outcome measures
Measure
TAP, Bupivacaine
n=12 Participants
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No Intervention
n=11 Participants
General anesthesia
Post Operative Opioid Usage
2.25 morphine equivalent
Interval 2.25 to 4.0
4 morphine equivalent
Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 30 minutes within arrival to PACU

Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU)

Outcome measures

Outcome measures
Measure
TAP, Bupivacaine
n=12 Participants
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No Intervention
n=11 Participants
General anesthesia
Pain Score Assessed With Visual Analog Score (VAS)
5.5 units on a scale
Interval 4.25 to 8.25
2 units on a scale
Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Up to 5 hours

The number of participants experiencing nausea will be assessed by chart review

Outcome measures

Outcome measures
Measure
TAP, Bupivacaine
n=12 Participants
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No Intervention
n=11 Participants
General anesthesia
Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review
5 Participants
3 Participants

SECONDARY outcome

Timeframe: Up to 5 hours

The number of participants experiencing vomiting will be assessed by chart review

Outcome measures

Outcome measures
Measure
TAP, Bupivacaine
n=12 Participants
This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Transverse abdominal plane block: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. Ropivacaine: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
No Intervention
n=11 Participants
General anesthesia
Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review
0 Participants
2 Participants

Adverse Events

TAP, Bupivacaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Intervention

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. Karina Gritsenko

Montefiore Medical Center

Phone: 718-920-7246

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place