Trial Outcomes & Findings for Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs (NCT NCT05672680)

NCT ID: NCT05672680

Last Updated: 2025-03-28

Results Overview

On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: on post-op days 1, 2, 3, and 4
• Results posted on: 2025-03-28

Participant Flow

Recruitment performed in outpatient office from 12/9/2019 to 07/23/2023.

Participant milestones

Measure	Placebo Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Overall Study STARTED	50	50
Overall Study COMPLETED	44	46
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	Placebo Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Overall Study Patient Did Not Complete the Form	5	4
Overall Study Procedure Aborted	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Total n=90 Participants Total of all reporting groups
Age, Continuous	58.07 years STANDARD_DEVIATION 13.67 • n=44 Participants	56.42 years STANDARD_DEVIATION 15.78 • n=46 Participants	57.24 years STANDARD_DEVIATION 14.71 • n=90 Participants
Sex: Female, Male Female	3 Participants n=44 Participants	2 Participants n=46 Participants	5 Participants n=90 Participants
Sex: Female, Male Male	41 Participants n=44 Participants	44 Participants n=46 Participants	85 Participants n=90 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: on post-op days 1, 2, 3, and 4

On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Pain Score at Rest post-op day 2	4.21 score on a scale Standard Deviation 2.49	4.53 score on a scale Standard Deviation 2.61
Pain Score at Rest post-op day 3	3.53 score on a scale Standard Deviation 2.39	3.77 score on a scale Standard Deviation 2.49
Pain Score at Rest post-op day 4	2.92 score on a scale Standard Deviation 2.39	3.19 score on a scale Standard Deviation 2.46
Pain Score at Rest post-op day 1	4.31 score on a scale Standard Deviation 2.46	4.55 score on a scale Standard Deviation 2.70

PRIMARY outcome

Timeframe: All post-op (average 4 days)

On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Pain Score at Rest	3.75 score on a scale Standard Deviation 2.48	4.01 score on a scale Standard Deviation 2.65

PRIMARY outcome

Timeframe: on post-op days 1, 2, 3, and 4

On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Pain Score at Movement post-op day 1	5.84 score on a scale Standard Deviation 2.42	6.35 score on a scale Standard Deviation 2.54
Pain Score at Movement post-op day 2	5.47 score on a scale Standard Deviation 2.56	6.16 score on a scale Standard Deviation 2.55
Pain Score at Movement post-op day 3	4.65 score on a scale Standard Deviation 2.21	4.99 score on a scale Standard Deviation 2.51
Pain Score at Movement post-op day 4	3.71 score on a scale Standard Deviation 2.37	4.31 score on a scale Standard Deviation 2.53

PRIMARY outcome

Timeframe: All post-op (average 4 days)

On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Pain Score at Movement	4.93 score on a scale Standard Deviation 2.51	5.46 score on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: on post-op days 1, 2, 3, and 4

Patients recorded the number of opioid pills taken.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Opioid Pills post-op day 2	1.25 number of pills Standard Deviation 1.62	1.35 number of pills Standard Deviation 1.48
Number of Opioid Pills post-op day 3	0.88 number of pills Standard Deviation 1.45	0.60 number of pills Standard Deviation 1.10
Number of Opioid Pills post-op day 4	1.21 number of pills Standard Deviation 1.54	0.77 number of pills Standard Deviation 1.26
Number of Opioid Pills post-op day 1	1.29 number of pills Standard Deviation 1.47	1.52 number of pills Standard Deviation 1.28

SECONDARY outcome

Timeframe: All post-op (average 4 days)

Patients recorded the number of opioid pills taken.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Opioid Pills	1.16 number of pills Standard Deviation 1.52	1.06 number of pills Standard Deviation 1.33

SECONDARY outcome

Timeframe: on post-op days 1, 2, 3, and 4

Patients recorded the number of non-opioid pills taken for pain control.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Non-opioid Pain Medication post-op day 3	0.85 number of pills Standard Deviation 1.04	0.77 number of pills Standard Deviation 0.96
Number of Non-opioid Pain Medication post-op day 4	0.77 number of pills Standard Deviation 0.98	0.65 number of pills Standard Deviation 0.82
Number of Non-opioid Pain Medication post-op day 1	0.76 number of pills Standard Deviation 1.03	0.71 number of pills Standard Deviation 1.09
Number of Non-opioid Pain Medication post-op day 2	1.07 number of pills Standard Deviation 1.22	0.78 number of pills Standard Deviation 1.05

SECONDARY outcome

Timeframe: All post-op (average 4 days)

Patients recorded the number of non-opioid pills taken for pain control.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Non-opioid Pain Medication	0.86 number of pills Standard Deviation 1.07	0.73 number of pills Standard Deviation 0.98

SECONDARY outcome

Timeframe: up to 2 weeks post-surgery

Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Intraoperative Complications Mortality	0 number of complications	0 number of complications
Number of Intraoperative Complications Urinary Retention	1 number of complications	2 number of complications
Number of Intraoperative Complications Early Recurrence	0 number of complications	1 number of complications
Number of Intraoperative Complications Hematoma	0 number of complications	1 number of complications
Number of Intraoperative Complications Induration	1 number of complications	1 number of complications

SECONDARY outcome

Timeframe: during procedure

Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Participants With Contents in the Hernia None	33 Participants	39 Participants
Number of Participants With Contents in the Hernia Bowel	1 Participants	0 Participants
Number of Participants With Contents in the Hernia Lipoma	10 Participants	6 Participants
Number of Participants With Contents in the Hernia Omentum	0 Participants	1 Participants
Number of Participants With Contents in the Hernia Bladder	0 Participants	0 Participants

SECONDARY outcome

Timeframe: during procedure

Population: There were a number of participants that were missing this data. This is due to human error for not inputting the information.

Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Surgical Tacks Used Per Repair 4	16 Participants	12 Participants
Number of Surgical Tacks Used Per Repair 5	0 Participants	3 Participants
Number of Surgical Tacks Used Per Repair 6	18 Participants	15 Participants
Number of Surgical Tacks Used Per Repair Data not collected	10 Participants	16 Participants

SECONDARY outcome

Timeframe: during procedure

Procedure duration in minutes.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Procedure Time	72.7 Minutes Standard Deviation 19.13	78.54 Minutes Standard Deviation 27.20

SECONDARY outcome

Timeframe: during procedure

Population: A participant was missing this data. This is due to human error for not inputting the information.

Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss Less than 25 milliliters	38 Participants	39 Participants
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss Greater than or equal to 25 milliliters	5 Participants	7 Participants
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss Data not collected	1 Participants	0 Participants

SECONDARY outcome

Timeframe: during procedure

The number of patients handled per anesthesiologist.

Outcome measures

Measure	Placebo n=44 Participants Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. Placebo: placebo equivalent TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).	Experimental n=46 Participants 0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received. 0.25% Bupivacaine: received during TAP block TAP block: The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Number of Patients Per Anesthesiologist Anesthesiologist 1	18 Participants	21 Participants
Number of Patients Per Anesthesiologist Anesthesiologist 2	3 Participants	2 Participants
Number of Patients Per Anesthesiologist Anesthesiologist 3	7 Participants	4 Participants
Number of Patients Per Anesthesiologist Anesthesiologist 4	16 Participants	19 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

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

Celia Divino

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-3348

Email: celia.divino@mountsinai.org

Results disclosure agreements

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