Trial Outcomes & Findings for A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques (NCT NCT02538679)

Last Updated: 2018-03-27

Results Overview

Compare ultrasound-guided block of the transversus abdominis plane (TAP) vs laparoscopic-guided TAP block, versus no TAP block on opioid consumption in the first 24 hours. Patients hospital chart was queried for use of any intravenous opioid in the first 24 hours after surgery including fentanyl or hydromorphone and conversion to morphine per standard opioid dose conversion. Total morphine equivalents then summed for the 24 hour postoperative period and compared between groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

127 participants

Primary outcome timeframe

24 hours

Results posted on

2018-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	PLACEBO No TAP block performed Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed	US TAP Bupivacaine/Epinephrine Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.	Lap TAP Bupivacaine/Epinephrine Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
Overall Study STARTED	24	54	49
Overall Study COMPLETED	21	45	41
Overall Study NOT COMPLETED	3	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PLACEBO n=21 Participants No TAP block performed Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed	US TAP Bupivacaine/Epinephrine n=45 Participants Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.	Lap TAP Bupivacaine/Epinephrine n=41 Participants Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.	Total n=107 Participants Total of all reporting groups
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 18.5 • n=5 Participants	54 years STANDARD_DEVIATION 16.6 • n=7 Participants	48.4 years STANDARD_DEVIATION 18.8 • n=5 Participants	50.2 years STANDARD_DEVIATION 18 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	22 Participants n=7 Participants	16 Participants n=5 Participants	50 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	30 Participants n=7 Participants	25 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
American Society of Anesthesiologist Classification ASA I/II	12 Participants n=5 Participants	28 Participants n=7 Participants	34 Participants n=5 Participants	74 Participants n=4 Participants
American Society of Anesthesiologist Classification ASA III or higher	9 Participants n=5 Participants	17 Participants n=7 Participants	7 Participants n=5 Participants	33 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	PLACEBO n=21 Participants No TAP block performed Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed	US TAP Bupivacaine/Epinephrine n=45 Participants Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.	Lap TAP Bupivacaine/Epinephrine n=41 Participants Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
Morphine Requirement	31.4 mg Standard Deviation 19.2	39 mg Standard Deviation 35.5	22.8 mg Standard Deviation 21.3

Adverse Events

PLACEBO

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

US TAP Bupivacaine/Epinephrine

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Lap TAP Bupivacaine/Epinephrine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PLACEBO n=21 participants at risk No TAP block performed Placebo: The usual intraoperative and postoperative pain control; NO TAP block performed	US TAP Bupivacaine/Epinephrine n=45 participants at risk Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. US TAP Bupivacaine/Epinephrine: Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.	Lap TAP Bupivacaine/Epinephrine n=41 participants at risk Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane. Lap TAP Bupivacaine/Epinephrine: Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
Gastrointestinal disorders Ileus	28.6% 6/21 • Number of events 6 • adverse events were recorded for the 30 day postoperative window	24.4% 11/45 • Number of events 11 • adverse events were recorded for the 30 day postoperative window	24.4% 10/41 • Number of events 10 • adverse events were recorded for the 30 day postoperative window
Surgical and medical procedures Other non-GI adverse events	9.5% 2/21 • adverse events were recorded for the 30 day postoperative window	13.3% 6/45 • adverse events were recorded for the 30 day postoperative window	12.2% 5/41 • adverse events were recorded for the 30 day postoperative window

Additional Information

Dr. Karen Zaghiyan

Cedars Sinai Medical center

Phone: 310-289-9224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place