Trial Outcomes & Findings for Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain (NCT NCT03854344)
NCT ID: NCT03854344
Last Updated: 2026-03-31
Results Overview
Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
The subject completes a pain assessment at 8 hours post-operatively.
Results posted on
2026-03-31
Participant Flow
Participant milestones
| Measure |
Group 3
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting
|
Group 1
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting
|
Group 2
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
25
|
|
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 |
Group 1
n=25 Participants
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting
|
Group 2
n=25 Participants
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting
|
Group 3
n=24 Participants
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
74 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=74 Participants
|
|
Age, Continuous
|
49.16 years
STANDARD_DEVIATION 15.89 • n=25 Participants
|
47 years
STANDARD_DEVIATION 17.45 • n=25 Participants
|
47.46 years
STANDARD_DEVIATION 19.17 • n=24 Participants
|
47.88 years
STANDARD_DEVIATION 17.31 • n=74 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
8 Participants
n=24 Participants
|
18 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
16 Participants
n=24 Participants
|
56 Participants
n=74 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
24 participants
n=24 Participants
|
74 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: The subject completes a pain assessment at 8 hours post-operatively.Population: Each group was planned for 25 subjects. We only enrolled 24 in the regional anesthesia group as we were able to achieve statistical significance at that number and did not require another subject to participate at that time.
Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine
Outcome measures
| Measure |
Group 1
n=25 Participants
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting
|
Group 2
n=25 Participants
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting
|
Group 3
n=24 Participants
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting
|
|---|---|---|---|
|
A Measurement of Post Operative Pain Involving Skin Graft Donor Site Using Visual Analog Scale (VAS) Ranging 0-10, at 8 Hours Post-operatively
|
3.14 score on a scale 0-10
Standard Deviation 2.78
|
3.68 score on a scale 0-10
Standard Deviation 2.80
|
3.67 score on a scale 0-10
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: 72 hours (3 days) post operativelyOpioid consumption will be measured by converting all opioids given to subjects to morphine equivalents
Outcome measures
| Measure |
Group 1
n=25 Participants
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting
|
Group 2
n=25 Participants
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting
|
Group 3
n=24 Participants
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting
|
|---|---|---|---|
|
Opioid Pain Medication Consumption up to 72 Hours Post-operatively Will be Compared Between the Subjects Who Are Given Liposomal Bupivacaine (Exparel) and Lidocaine at the Donor Sites
|
36.21 MME
Standard Deviation 30.69
|
49.91 MME
Standard Deviation 42.09
|
44.59 MME
Standard Deviation 31.71
|
SECONDARY outcome
Timeframe: Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 72 hours after surgery. They will be compared between the groups.Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine
Outcome measures
| Measure |
Group 1
n=25 Participants
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Liposomal bupivacaine: Injected subcutaneously for skin graft harvesting
|
Group 2
n=25 Participants
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Lidocaine Hydrochloride: Injected subcutaneously for skin graft harvesting
|
Group 3
n=24 Participants
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Bupivacaine Hydrochloride: Used for regional nerve block for skin graft harvesting
|
|---|---|---|---|
|
Pain Scores Over 72 Hours After Surgery
|
4.88 Pain score 1-10
Standard Deviation 2.14
|
3.64 Pain score 1-10
Standard Deviation 2.59
|
3 Pain score 1-10
Standard Deviation 2.17
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place