Trial Outcomes & Findings for Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair (NCT NCT03541941)

NCT ID: NCT03541941

Last Updated: 2021-10-12

Results Overview

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. The cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations will be recorded. Such assessment will be performed at the 3rd postoperative day (72 hours of operation).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 164 participants
• Primary outcome timeframe: Measured from end of surgery until 72 hours after the surgery
• Results posted on: 2021-10-12

Participant Flow

Participant milestones

Measure	Exparel Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Overall Study STARTED	57	55	52
Overall Study COMPLETED	57	55	52
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block	Total n=164 Participants Total of all reporting groups
Age, Continuous	59.0 years n=57 Participants	58.0 years n=55 Participants	60.0 years n=52 Participants	59.0 years n=164 Participants
Sex: Female, Male Female	25 Participants n=57 Participants	27 Participants n=55 Participants	29 Participants n=52 Participants	81 Participants n=164 Participants
Sex: Female, Male Male	32 Participants n=57 Participants	28 Participants n=55 Participants	23 Participants n=52 Participants	83 Participants n=164 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	57 participants n=57 Participants	55 participants n=55 Participants	52 participants n=52 Participants	164 participants n=164 Participants

PRIMARY outcome

Timeframe: Measured from end of surgery until 72 hours after the surgery

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. The cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations will be recorded. Such assessment will be performed at the 3rd postoperative day (72 hours of operation).

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Cumulative Opioid Requirements for 72 Hours After Surgery	325 mg morphine equivalents/day Standard Deviation 225	350 mg morphine equivalents/day Standard Deviation 284	310 mg morphine equivalents/day Standard Deviation 272

PRIMARY outcome

Timeframe: From end of surgery until the end of postoperative day 0 (23:59pm of postoperative day 0)

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. The cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparation will be measured at postoperative day 0 (day of surgery).

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Cumulative Opioid Requirements at Postoperative Day 0	68.3 mg morphine equivalents/day Standard Deviation 49.8	77.1 mg morphine equivalents/day Standard Deviation 62.5	74.5 mg morphine equivalents/day Standard Deviation 54

PRIMARY outcome

Timeframe: From 00:00am of postoperative day 1 until (23:59pm of postoperative day 1)

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations, measured at postoperative day 1

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Cumulative Opioid Requirements at Postoperative Day 1	116 mg morphine equivalents/day Standard Deviation 81.7	116 mg morphine equivalents/day Standard Deviation 100	105 mg morphine equivalents/day Standard Deviation 92.1

PRIMARY outcome

Timeframe: From 00:00 of postoperative day 2 until 23:59pm of postoperative day 2

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations, measured at postoperative day 2

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Cumulative Opioid Requirements at Postoperative Day 2	79.9 mg morphine equivalents/day Standard Deviation 69.8	96.7 mg morphine equivalents/day Standard Deviation 94	79.9 mg morphine equivalents/day Standard Deviation 97.4

PRIMARY outcome

Timeframe: From 00:00 of postoperative day 3 until 23:59pm of postoperative day 3

Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose. Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations, measured at postoperative day 3

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Cumulative Opioid Requirements at Postoperative Day 3	60.9 mg morphine equivalents/day Standard Deviation 56.4	60.4 mg morphine equivalents/day Standard Deviation 68.5	50.9 mg morphine equivalents/day Standard Deviation 68.9

SECONDARY outcome

Timeframe: Measured from end of surgery until the time of hospital discharge, up to a maximum of 6 days

Cumulative dose of opioids administered intravenously (infused through a patient-controlled analgesia device as well as the quantity of opioids administered intravenously as rescue, if needed) and the quantity of opioids administered through oral preparations administered during the entire length of hospital stay. Measured in milligrams or micrograms as appropriate and converted to oral morphine equivalent daily dose.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Opioid Requirements for Total Length of Hospital Stay	50.5 mg morphine equivalents/day Standard Deviation 17.2	50.1 mg morphine equivalents/day Standard Deviation 19.1	51.0 mg morphine equivalents/day Standard Deviation 20.5

SECONDARY outcome

Timeframe: Measured once, from end of surgery until the end of postoperative day 0 (23:59pm of the day of surgery)

Measured using a 100mm Visual Analog Scale, at the end of the first of postoperative day 0 (day of surgery).

The scale ranges from 0mm (No pain) to 100mm (Pain as bad as it could possibly be). A paper-based version of the VAS will be used, containing a 100mm line, where the left-end (0mm) contains the sentence "No Pain" and in the right-end (100mm) contains the sentence "Pain as bad as it could possibly be". Patients will be asked to indicate on the line where the pain is in relation to the two extremes. This will be performed with a pen. Measure with a ruler will be performed from the left hand side to the mark and this will be recorded in mm. Lower values represent less pain and higher values represent more pain. There are no subscale components for this measurement.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Pain Scores at Postoperative Day 0	20.0 score on a scale Interval 1.0 to 57.0	16.0 score on a scale Interval 2.0 to 42.5	21.5 score on a scale Interval 2.0 to 32.2

SECONDARY outcome

Timeframe: Measured once, from 00:00am of postoperative day 1 until the end of postoperative day 1 (23:59pm of postoperative day 1)

Measured using a 100mm Visual Analog Scale, at the end of the postoperative day 1.

The scale ranges from 0mm (No pain) to 100mm (Pain as bad as it could possibly be). A paper-based version of the VAS will be used, containing a 100mm line, where the left-end (0mm) contains the sentence "No Pain" and in the right-end (100mm) contains the sentence "Pain as bad as it could possibly be". Patients will be asked to indicate on the line where the pain is in relation to the two extremes. This will be performed with a pen. Measure with a ruler will be performed from the left hand side to the mark and this will be recorded in mm. Lower values represent less pain and higher values represent more pain. There are no subscale components for this measurement.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Pain Scores at Postoperative Day 1	58.0 score on a scale Interval 27.0 to 73.0	49.0 score on a scale Interval 32.5 to 70.5	42.5 score on a scale Interval 23.0 to 60.0

SECONDARY outcome

Timeframe: Measured once, from 00:00am of postoperative day 2 until the end of postoperative day 2 (23:59pm of postoperative day 2)

Measured using a 100mm Visual Analog Scale, at the end of the postoperative day 2 The scale ranges from 0mm (No pain) to 100mm (Pain as bad as it could possibly be). A paper-based version of the VAS will be used, containing a 100mm line, where the left-end (0mm) contains the sentence "No Pain" and in the right-end (100mm) contains the sentence "Pain as bad as it could possibly be". Patients will be asked to indicate on the line where the pain is in relation to the two extremes. This will be performed with a pen. Measure with a ruler will be performed from the left hand side to the mark and this will be recorded in mm. Lower values represent less pain and higher values represent more pain. There are no subscale components for this measurement.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Pain Scores at Postoperative Day 2	56.0 score on a scale Interval 32.0 to 69.0	39.0 score on a scale Interval 25.5 to 56.5	42.5 score on a scale Interval 21.5 to 56.2

SECONDARY outcome

Timeframe: Measured once, from 00:00am of postoperative day 3 until the end of postoperative day 3 (23:59pm of postoperative day 3)

Measured using a 100mm Visual Analog Scale, at the end of the postoperative day 3 The scale ranges from 0mm (No pain) to 100mm (Pain as bad as it could possibly be). A paper-based version of the VAS will be used, containing a 100mm line, where the left-end (0mm) contains the sentence "No Pain" and in the right-end (100mm) contains the sentence "Pain as bad as it could possibly be". Patients will be asked to indicate on the line where the pain is in relation to the two extremes. This will be performed with a pen. Measure with a ruler will be performed from the left hand side to the mark and this will be recorded in mm. Lower values represent less pain and higher values represent more pain. There are no subscale components for this measurement.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Pain Scores at Postoperative Day 3	46.0 score on a scale Interval 26.0 to 74.0	45.0 score on a scale Interval 24.0 to 60.0	40.0 score on a scale Interval 22.0 to 51.5

SECONDARY outcome

Timeframe: From the day of surgery until the day of hospital discharge, up to a maximum of 30 days

Measured in days, being the difference from day of surgery until the day of hospital discharge.

The scale ranges from 0mm (No pain) to 100mm (Pain as bad as it could possibly be). A paper-based version of the VAS will be used, containing a 100mm line, where the left-end (0mm) contains the sentence "No Pain" and in the right-end (100mm) contains the sentence "Pain as bad as it could possibly be". Patients will be asked to indicate on the line where the pain is in relation to the two extremes. This will be performed with a pen. Measure with a ruler will be performed from the left hand side to the mark and this will be recorded in mm. Lower values represent less pain and higher values represent more pain. There are no subscale components for this measurement.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Length of Hospital Stay	5.00 Days Interval 5.0 to 7.0	5.00 Days Interval 5.0 to 6.0	5.00 Days Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: Measured during the 30-day follow-up visit, expected to occur 30-days after the day of surgery, up to a maximum of 90 days

Measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey. This survey has 3 questions:(1) How intense was your pain as its worst? (2) How intense was your average pain? and (3) What is your level of pain right now?. Each question has 5 response options ranging in value from 1 to 5. To find the total raw score, sum of the values for each question is performed; lowest possible raw score is 3 and highest possible raw score is 15.A raw score of 10 converts to a T-score of 54.5 with a standard error (SE) of 2.9. Thus, the 95% confidence interval around the observed score ranges from 48.8 to 54.5 (T-score + (1.96*SE) or 54.5 + (1.96*2.9). A score of 50 is the average for the United States general population with a standard deviation of 10. For negatively-worded concepts like Pain Intensity, a T-score of 60 is one SD worse than average. By comparison, a Pain Intensity Tscore of 40 is one SD better than average.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
30-day Pain Scores	19.0 T-Score Interval 4.0 to 50.0	16.5 T-Score Interval 4.0 to 50.0	11.0 T-Score Interval 3.0 to 26.0

SECONDARY outcome

Timeframe: Measured during the 30-day follow-up visit, expected to occur 30-days after the day of surgery, up to a maximum of 90 days

Measured using the Hernia Related Quality of Life survey (HerQLes) during the 30-day follow-up visit. The HerQLes is a valid and reliable hernia-specific quality of life measure. Each questions has 6 response options ranging in value from one to six. To find the raw score for the HerQles, a sum of the values of the response to each question is performed. For example, the lowest possible score is 12; the highest possible score is 72. All questions must be answered to provide a valid score. Mean and standard deviations of the scores of the entire study population will be calculated. Next, the Z score will be calculated as follows:

(Raw score-mean) / Standard Deviation. Next step is to calculate the Standard Score, as follows: (-(Z score)*Mean)+Standard Deviation. The standard score will be used for comparisons and reports, and should provide a value ranging from 0 to 100. Lower scores means lower quality of life and higher scores means higher quality of life.

Outcome measures

Measure	Exparel n=57 Participants Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 Participants Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 Participants 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
30-day Patient-Reported Quality of Life	46.9 Z-Score Standard Deviation 29.1	38.4 Z-Score Standard Deviation 24.3	45.2 Z-Score Standard Deviation 23.5

Adverse Events

Exparel

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Bupivacaine Hcl 0.25% Inj

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exparel n=57 participants at risk Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 participants at risk Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 participants at risk 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/57 • 30 days following surgery	1.8% 1/55 • Number of events 1 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Vascular disorders Pulmonary Embolism	1.8% 1/57 • Number of events 1 • 30 days following surgery	1.8% 1/55 • Number of events 1 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Cardiac disorders Cardiac Arrest	0.00% 0/57 • 30 days following surgery	1.8% 1/55 • Number of events 1 • 30 days following surgery	0.00% 0/52 • 30 days following surgery

Other adverse events

Measure	Exparel n=57 participants at risk Solution of 266mg of Exparel + 150mg Bupivacaine HCL + 40cc normal saline= 120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Exparel: Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Bupivacaine Hcl 0.25% Inj n=55 participants at risk Solution of 150mg Bupivacaine HCL expanded with 60cc of normal saline=120cc administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Bupivacaine Hcl 0.25% Inj: Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block	Placebo n=52 participants at risk 120 cc of normal saline administered through a transversus abdominis plane block performed intraoperatively by the surgeon under direct visualization Placebo: Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
Gastrointestinal disorders Ileus	24.6% 14/57 • Number of events 14 • 30 days following surgery	20.0% 11/55 • Number of events 11 • 30 days following surgery	11.5% 6/52 • Number of events 6 • 30 days following surgery
Nervous system disorders Stroke	0.00% 0/57 • 30 days following surgery	0.00% 0/55 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Vascular disorders Deep Vein Thrombosis	0.00% 0/57 • 30 days following surgery	1.8% 1/55 • Number of events 1 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Infections and infestations Sepsis	0.00% 0/57 • 30 days following surgery	1.8% 1/55 • Number of events 1 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Infections and infestations Septic Shock	0.00% 0/57 • 30 days following surgery	0.00% 0/55 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Cardiac disorders Myocardial Infarction	0.00% 0/57 • 30 days following surgery	1.8% 1/55 • Number of events 1 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Renal and urinary disorders Renal Insufficiency	0.00% 0/57 • 30 days following surgery	0.00% 0/55 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Renal and urinary disorders Acute Renal Failure	0.00% 0/57 • 30 days following surgery	0.00% 0/55 • 30 days following surgery	1.9% 1/52 • Number of events 1 • 30 days following surgery
Infections and infestations Pneumonia	1.8% 1/57 • Number of events 1 • 30 days following surgery	5.5% 3/55 • Number of events 3 • 30 days following surgery	0.00% 0/52 • 30 days following surgery
Musculoskeletal and connective tissue disorders Pain	0.00% 0/57 • 30 days following surgery	0.00% 0/55 • 30 days following surgery	0.00% 0/52 • 30 days following surgery

Additional Information

Dr. Michael Rosen

Cleveland Clinic Foundation

Phone: 216-445-3441

Email: rosenm@ccf.org

Results disclosure agreements

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