Trial Outcomes & Findings for Comparing TAP Blocks Bupivacaine, and Placebo for Plane (NCT NCT04685876)

NCT ID: NCT04685876

Last Updated: 2025-08-27

Results Overview

Opioid consumption, measured in morphine milligram equivalents, during the first 24 hours of surgery

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 285 participants
• Primary outcome timeframe: Postoperative 24 hours
• Results posted on: 2025-08-27

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
Overall Study STARTED	96	94	95
Overall Study COMPLETED	89	84	88
Overall Study NOT COMPLETED	7	10	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=89 Participants 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=84 Participants 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=88 Participants patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).	Total n=261 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 14 • n=89 Participants	59 years STANDARD_DEVIATION 13 • n=84 Participants	59 years STANDARD_DEVIATION 15 • n=88 Participants	58 years STANDARD_DEVIATION 14 • n=261 Participants
Sex: Female, Male Female	43 Participants n=89 Participants	39 Participants n=84 Participants	40 Participants n=88 Participants	122 Participants n=261 Participants
Sex: Female, Male Male	46 Participants n=89 Participants	45 Participants n=84 Participants	48 Participants n=88 Participants	139 Participants n=261 Participants
Race/Ethnicity, Customized Black	9 Participants n=88 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	8 Participants n=82 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	9 Participants n=84 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	26 Participants n=254 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)
Race/Ethnicity, Customized Hispanic	2 Participants n=88 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	0 Participants n=82 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	2 Participants n=84 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	4 Participants n=254 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)
Race/Ethnicity, Customized Asian	1 Participants n=88 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	0 Participants n=82 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	1 Participants n=84 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	2 Participants n=254 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)
Race/Ethnicity, Customized White	75 Participants n=88 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	73 Participants n=82 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	71 Participants n=84 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	219 Participants n=254 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)
Race/Ethnicity, Customized Other	1 Participants n=88 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	1 Participants n=82 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	1 Participants n=84 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)	3 Participants n=254 Participants • Data on ethnicity was missing/not collected for some patients (n=1 in liposomal bupivacaine group, n=2 for plain bupivaacine group and n=4 for plain saline group)
BMI	32 kg/m^2 STANDARD_DEVIATION 6 • n=89 Participants	31 kg/m^2 STANDARD_DEVIATION 6 • n=84 Participants	32 kg/m^2 STANDARD_DEVIATION 6 • n=88 Participants	32 kg/m^2 STANDARD_DEVIATION 6 • n=261 Participants

PRIMARY outcome

Timeframe: Postoperative 24 hours

Population: Modified intention to treat population

Opioid consumption, measured in morphine milligram equivalents, during the first 24 hours of surgery

Outcome measures

Measure	Liposomal Bupivacaine n=89 Participants 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=84 Participants 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=85 Participants patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
Total Opioids During Postoperative 24 Hours	26 morphine milligram equivalents Interval 18.0 to 48.0	33 morphine milligram equivalents Interval 13.0 to 75.0	31 morphine milligram equivalents Interval 17.0 to 53.0

PRIMARY outcome

Timeframe: Postoperative 24 to 48 hours

Population: Modified intention to treat population

Total opioid consumption, in morphine milligram, equivalents, during postoperative 24 to 48 hours.

Outcome measures

Measure	Liposomal Bupivacaine n=89 Participants 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=84 Participants 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=88 Participants patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
Total Opioid Consumption During Postoperative 24 to 48 Hours	10 morphine milligram equivalents Interval 2.0 to 25.0	19 morphine milligram equivalents Interval 5.0 to 42.0	15 morphine milligram equivalents Interval 5.0 to 27.0

SECONDARY outcome

Timeframe: 72 hours

The investigator evaluate when patients feels both ice and pinprick in at least 6 of the 8 designated test locations, or 75% of the covered points if the TAP block did not initially cover all eight locations. The outcome is time (days) until sensation is recovered in 75% of the covered points.

Outcome measures

Measure	Liposomal Bupivacaine n=79 Participants 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=73 Participants 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=83 Participants patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
Time to Return of Sensation	0 days Interval 0.0 to 0.0	0 days Interval 0.0 to 0.0	0 days Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Postoperative 72 hours

Pain scores measured using the numeric rating scale (NRS) going from 0 to 10, with 0 representing least pain and 10 representing most pain.

Outcome measures

Measure	Liposomal Bupivacaine n=89 Participants 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=83 Participants 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=88 Participants patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
Pain Scores During Postoperative 72 Hours	4 units on a scale Interval 3.0 to 6.0	5 units on a scale Interval 3.0 to 6.0	4 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Postoperative 48 to 72 hours

Total opioid consumption, in morphine milligram equivalents, during postoperative 48 to 72 hours.

Outcome measures

Measure	Liposomal Bupivacaine n=89 Participants 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=84 Participants 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=88 Participants patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
Total Opioid Consumption (Postoperative 48 to 72 Hours)	5 morphine milligram equivalents Interval 0.0 to 15.0	9 morphine milligram equivalents Interval 1.0 to 26.0	10 morphine milligram equivalents Interval 0.0 to 18.0

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Plain Bupivacaine

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Liposomal Bupivacaine n=96 participants at risk 40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block. Liposomal bupivacaine: 4-quadrant TAP block with liposomal bupivacaine	Plain Bupivacaine n=94 participants at risk 50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block. Plain bupivacaine: 4-quadrant TAP block with plain bupivacaine	Normal Saline n=95 participants at risk patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites. Normal saline: placebo (normal saline).
General disorders Opioid related side effects	64.6% 62/96 • Until discharge (approximately 5 days)	60.6% 57/94 • Until discharge (approximately 5 days)	73.7% 70/95 • Until discharge (approximately 5 days)

Additional Information

Dr. Alparslan Turan

University of Texas, Houston

Phone: 713-500-6279

Email: Mehmet.A.Turan@uth.tmc.edu

Results disclosure agreements

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