Trial Outcomes & Findings for Pain Management in Response to Exparel vs. Standard Bupivicaine (NCT NCT02499159)

NCT ID: NCT02499159

Last Updated: 2021-02-16

Results Overview

Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Assessed daily for 7 days post-procedure
• Results posted on: 2021-02-16

Participant Flow

Participant milestones

Measure	Exparel Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Randomization STARTED	50	50
Randomization COMPLETED	49	49
Randomization NOT COMPLETED	1	1
30-Day Follow-Up Phone Call STARTED	49	49
30-Day Follow-Up Phone Call COMPLETED	42	47
30-Day Follow-Up Phone Call NOT COMPLETED	7	2

Reasons for withdrawal

Measure	Exparel Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Randomization Protocol Violation	1	1
30-Day Follow-Up Phone Call Withdrawal by Subject	1	1
30-Day Follow-Up Phone Call Lost to Follow-up	3	1
30-Day Follow-Up Phone Call Withdrawal due to ineligibility	2	0
30-Day Follow-Up Phone Call Other	1	0

Baseline Characteristics

Pain Management in Response to Exparel vs. Standard Bupivicaine

Baseline characteristics by cohort

Measure	Exparel n=49 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=49 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.	Total n=98 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 10.9 • n=5 Participants	65 years STANDARD_DEVIATION 10.8 • n=7 Participants	64 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	49 participants n=7 Participants	98 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed daily for 7 days post-procedure

Population: 4 participants from the Exparel group and 6 participants from the standard group did not return a questionnaire.

Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.

Outcome measures

Measure	Exparel n=45 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=44 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Overall Amounts of Pain Medications Consumed Through Post-operative Day 7	1294 tablets	1455.5 tablets

SECONDARY outcome

Timeframe: Assessed at day 7 post-procedure

Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.

Outcome measures

Measure	Exparel n=49 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=49 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Scores on a Analog Pain Scale (7 Days)	1.5 Median score on postoperative day 7 Interval 1.0 to 3.0	1 Median score on postoperative day 7 Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Assessed at 30 days post-procedure

Population: 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.

Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.

Outcome measures

Measure	Exparel n=42 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=47 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Scores on an Analog Pain Scale (30 Days)	0 Median score on postoperative day 30 Interval 0.0 to 0.0	0 Median score on postoperative day 30 Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: Assessed at day 7 post-procedure

Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.

Outcome measures

Measure	Exparel n=49 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=49 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Number of Patients With Paresthesias (Postoperatively at 7 Days)	10 Participants	20 Participants

SECONDARY outcome

Timeframe: Assessed at day 30 post-procedure

Population: 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.

Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves

Outcome measures

Measure	Exparel n=42 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=47 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Proportion of Patients With Paresthesias (Postoperatively at 30 Days)	6 Participants	5 Participants

SECONDARY outcome

Timeframe: From end of procedure until discharge, usually 0-2 days.

Median length of stay in days until discharge.

Outcome measures

Measure	Exparel n=49 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=49 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Hospital Length of Stay	0 days Interval 0.0 to 1.0	0 days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Assessed at 30 days post-procedure

Population: 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30 day survey.

Using surveys, patients are asked if they have been able to return to baseline activity levels.

Outcome measures

Measure	Exparel n=42 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=47 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Return to Baseline Activity	40 Participants	47 Participants

SECONDARY outcome

Timeframe: Assessed at 30 days post-procedure

Population: 42 subjects in the Exparel group and 47 patients in the standard group completed the 30-day survey.

Using surveys, patients are asked if they have been able to return to work.

Outcome measures

Measure	Exparel n=42 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=47 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Return to Work	24 Participants	17 Participants

SECONDARY outcome

Timeframe: Assessed at 30 days post-procedure

Population: At the 30-day call, 24 subjects in the Exparel group and 17 subjects in the standard group indicated that they were able to return to work. Number of days were assessed for these subjects.

Using surveys, the number of days to return to work was assessed for patients who were able to return to work.

Outcome measures

Measure	Exparel n=24 Participants Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=17 Participants Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Days Until Return to Work	6.5 days Interval 3.0 to 10.0	5 days Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Total cost assessed from patient registration until discharge to home (usually 0-2 days).

Population: Data on hospital cost was not collected.

Overall hospital cost of patient procedure and stay will be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Exparel

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

0.25% Standard Bupivicaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exparel n=49 participants at risk Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=49 participants at risk Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Psychiatric disorders Hospitalization	2.0% 1/49 • Number of events 1 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.	0.00% 0/49 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.

Other adverse events

Measure	Exparel n=49 participants at risk Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.	0.25% Standard Bupivicaine n=49 participants at risk Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Nervous system disorders Amaurosis Fugax	2.0% 1/49 • Number of events 1 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.	0.00% 0/49 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.
Blood and lymphatic system disorders Nose bleeds	2.0% 1/49 • Number of events 2 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.	0.00% 0/49 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.
Renal and urinary disorders Urinary blockage	2.0% 1/49 • Number of events 1 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.	0.00% 0/49 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.
Nervous system disorders Brain tumor	2.0% 1/49 • Number of events 1 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.	0.00% 0/49 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.
Nervous system disorders Occipital Neuralgia	2.0% 1/49 • Number of events 1 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.	0.00% 0/49 • From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.

Additional Information

Devon Collins

Inova Health System

Phone: 703-776-4096

Email: Devon.Collins@inova.org

Results disclosure agreements

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