Trial Outcomes & Findings for Exparel Versus Bupivacaine in Post-operative Pain Control (NCT NCT06547255)
NCT ID: NCT06547255
Last Updated: 2026-07-28
Results Overview
Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Twice daily (morning and evening) from 0-96 hours post-operatively
Results posted on
2026-07-28
Participant Flow
Participant milestones
| Measure |
Standard Bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine.
Bupivacaine liposome injectable suspension: At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.
|
Liposomal Bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
Bupivacaine liposome injectable suspension: At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Standard Bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine.
Bupivacaine liposome injectable suspension: At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.
|
Liposomal Bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
Bupivacaine liposome injectable suspension: At the end of the third molar extraction surgical procedure performed under general anesthesia and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine nerve block (routine for this procedure), all patients will receive bilateral infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) OR with 3mL of 0.5% bupivacaine with 1:200,000 epinephrine while they are still under general anesthesia.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
Baseline Characteristics
The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
Baseline characteristics by cohort
| Measure |
Standard Bupivicaine
n=50 Participants
patient receive mandibular and maxillary infiltrations with 3mL of standard 0.5% standard bupivacaine.
|
Liposomal Bupivacaine
n=50 Participants
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 6.9 • n=50 Participants
|
22.4 years
STANDARD_DEVIATION 5.6 • n=50 Participants
|
23.4 years
STANDARD_DEVIATION 6.3 • n=100 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=50 Participants • The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
|
34 Participants
n=50 Participants • The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
|
73 Participants
n=100 Participants • The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
|
|
Sex: Female, Male
Male
|
11 Participants
n=50 Participants • The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
|
16 Participants
n=50 Participants • The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
|
27 Participants
n=100 Participants • The number of participants analyzed in each category equals the total baseline population, and no participants were excluded from baseline analysis.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ASA Physical status classification
ASA I
|
36 Participants
n=50 Participants
|
47 Participants
n=50 Participants
|
83 Participants
n=100 Participants
|
|
ASA Physical status classification
ASA II
|
14 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
17 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Twice daily (morning and evening) from 0-96 hours post-operativelyPopulation: A total of 82 participants completed the study and were included in the final analysis (40 in the liposomal bupivacaine group and 42 in the standard bupivacaine group). Only participants with complete post operative pain data were included.
Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire
Outcome measures
| Measure |
Liposomal Bupivacaine
n=40 Participants
patients receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
|
Standard Bupivicaine
n=42 Participants
patients receive mandibular and maxillary infiltrations with 3mL of standard 0.5% standard bupivacaine.
|
|---|---|---|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 2 morning
|
3.3 VAS score 0-10
Standard Deviation 1.8
|
6.9 VAS score 0-10
Standard Deviation 2.4
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 2 evening
|
2.9 VAS score 0-10
Standard Deviation 1.8
|
7.0 VAS score 0-10
Standard Deviation 2.2
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 4 evening
|
1.4 VAS score 0-10
Standard Deviation 2.0
|
6.0 VAS score 0-10
Standard Deviation 2.5
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Evening of surgery
|
5.7 VAS score 0-10
Standard Deviation 1.9
|
6.9 VAS score 0-10
Standard Deviation 1.4
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 1 morning
|
4.6 VAS score 0-10
Standard Deviation 1.7
|
6.4 VAS score 0-10
Standard Deviation 2.5
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 1 evening
|
3.9 VAS score 0-10
Standard Deviation 1.7
|
6.5 VAS score 0-10
Standard Deviation 2.7
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 3 morning
|
2.6 VAS score 0-10
Standard Deviation 1.6
|
6.8 VAS score 0-10
Standard Deviation 2.2
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 3 evening
|
2.4 VAS score 0-10
Standard Deviation 1.4
|
6.8 VAS score 0-10
Standard Deviation 2.3
|
|
Post Operative Pain Intensity (Visual Analog Scale VAS)
Day 4 morning
|
1.6 VAS score 0-10
Standard Deviation 1.8
|
6.4 VAS score 0-10
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Daily from 0 to 96 hours post-operativelyPost operative analgesic consumption was recorded using a standardized at home questionnaire. Patients document the number of NSAIDS (Ibuprofen 600mg) and Acetaminophen tablets taken daily for four consecutive postoperative days.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=40 Participants
patients receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
|
Standard Bupivicaine
n=42 Participants
patients receive mandibular and maxillary infiltrations with 3mL of standard 0.5% standard bupivacaine.
|
|---|---|---|
|
Post Operative NSAID/Acetaminophen Consumption
Day of surgery
|
1.3 number of tablets
Standard Deviation 0.6
|
1.7 number of tablets
Standard Deviation 1
|
|
Post Operative NSAID/Acetaminophen Consumption
Post op day 1
|
2.3 number of tablets
Standard Deviation 1
|
2.9 number of tablets
Standard Deviation 1.3
|
|
Post Operative NSAID/Acetaminophen Consumption
Post op day 2
|
2 number of tablets
Standard Deviation 0.6
|
3.1 number of tablets
Standard Deviation 1.2
|
|
Post Operative NSAID/Acetaminophen Consumption
Post op day 3
|
1.8 number of tablets
Standard Deviation 1
|
3.0 number of tablets
Standard Deviation 1.4
|
|
Post Operative NSAID/Acetaminophen Consumption
Post op day 4
|
1.1 number of tablets
Standard Deviation 1
|
2.8 number of tablets
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: daily from 0 to 96 hours post-operativelypost operative opioid consumption was recorded using a standardized at home qusetionnaire. patients documented the number of (Hydrocodone-Acetaminophen 5/325) tablets taken daily for four consecutive postoperative days
Outcome measures
| Measure |
Liposomal Bupivacaine
n=40 Participants
patients receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
|
Standard Bupivicaine
n=42 Participants
patients receive mandibular and maxillary infiltrations with 3mL of standard 0.5% standard bupivacaine.
|
|---|---|---|
|
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
day of surgery
|
1.0 number of tablets
Standard Deviation 0.6
|
1.5 number of tablets
Standard Deviation 1.1
|
|
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
post op day 1
|
1.3 number of tablets
Standard Deviation 0.9
|
2.0 number of tablets
Standard Deviation 1.0
|
|
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
post op day 2
|
0.9 number of tablets
Standard Deviation 0.9
|
2.3 number of tablets
Standard Deviation 0.9
|
|
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
post op day 3
|
0.5 number of tablets
Standard Deviation 0.9
|
1.8 number of tablets
Standard Deviation 1.1
|
|
Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use
post op day 4
|
0.3 number of tablets
Standard Deviation 0.6
|
1.6 number of tablets
Standard Deviation 1.3
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard Bupivicaine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liposomal Bupivacaine
n=40 participants at risk
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
|
Standard Bupivicaine
n=42 participants at risk
patient receive mandibular and maxillary infiltrations with 3mL of standard 0.5% standard bupivacaine.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
17.5%
7/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
11.9%
5/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
Nervous system disorders
Headache
|
17.5%
7/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
7.1%
3/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
Nervous system disorders
Light headedness
|
15.0%
6/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
7.1%
3/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
Nervous system disorders
Dysgeusia
|
5.0%
2/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
0.00%
0/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
0.00%
0/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
General disorders
Fever
|
5.0%
2/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
2.4%
1/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
Nervous system disorders
Abnormal sensation
|
2.5%
1/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
0.00%
0/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
|
Cardiac disorders
Palpitation
|
2.5%
1/40 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
0.00%
0/42 • from the time of surgery to 96 hours post operatively
Adverse events were assessed using standardized at home questionnaire completed by participants during the 96 hours post operatively. All participants who completed the study (N=82) were included in the adverse event analysis. Events were self reported and recorded as present or absent
|
Additional Information
Mohammed Louay Taifour, DMD
Case Western Reserve University
Phone: 440-749-7865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place