A Phase 4 interventional study of Lidocaine Hydrochloride and Liposomal bupivacaine in Pain, Postoperative and Burns, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University of Kansas Medical Center · Phase 4, Interventional, and Treatment
Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.
The first phase of the study was a randomized controlled study. In the second phase, all subjects will receive fascia iliaca, lateral femoral cutaneous, or femoral nerve blocks based on the proposed donor site location and will be compared to historic controls from the first phase. In the first phase, the control group underwent split thickness autografting using the standard protocol, involving injection of lidocaine with epinephrine at the donor site. In the first phase, the experimental group underwent injection of liposomal bupivacaine (Exparel) at the time of harvest of the skin graft. In the second phase, patients will undergo preoperative regional anesthesia with a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location rather than the standard protocol of lidocaine with epinephrine at the donor site. Thus, in the second phase, group 3 (preoperative block group) will be compared to historic controls which received the standard of care in the first phase of this trial. Baseline pain levels will be obtained for all subjects using a validated pain assessment scale, the Visual Analog Pain Scale. Postoperatively, time to first opioid pain medication (excluding immediate postoperative recovery from anesthesia), total opioid consumption on a daily basis, and donor site interval pain scores using a validated pain assessment scale will be obtained. The experimental groups will then be individually compared to the control group to determine if there is a significant difference in pain levels, time to first opioid, and overall opioid consumption between the groups.
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This study's enrollment of 74 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Drug: Liposomal bupivacaine
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Drug: Lidocaine Hydrochloride
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
Drug: Bupivacaine Hydrochloride
Injected subcutaneously for skin graft harvesting
Injected subcutaneously for skin graft harvesting
Also known as: Exparel
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
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
Time frame: The subject completes a pain assessment at 8 hours post-operatively.
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
Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents
Time frame: 72 hours (3 days) post operatively
Pain Scores Over 72 Hours After Surgery
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
Time frame: 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.
| Milestone | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Started | 25 | 25 | 24 |
| Completed | 25 | 25 | 24 |
| Not completed | 0 | 0 | 0 |
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
| score on a scale 0-10 | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| 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 ± 2.78 | 3.68 ± 2.80 | 3.67 ± 3.32 |
Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents
| MME | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| 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 ± 30.69 | 49.91 ± 42.09 | 44.59 ± 31.71 |
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
| Pain score 1-10 | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Pain Scores Over 72 Hours After Surgery | 4.88 ± 2.14 | 3.64 ± 2.59 | 3 ± 2.17 |
Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Group 2 | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Group 3 | 0/24 (0%) | 0/24 (0%) | 0/25 (0%) |
All patients underwent skin grating surgery for full thickness burn injury.
| Age, Categorical(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 25 | 24 | 74 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Mean | 49.16 ± 15.89 | 47 ± 17.45 | 47.46 ± 19.17 | 47.88 ± 17.31 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Female | 5 | 5 | 8 | 18 |
| Male | 20 | 20 | 16 | 56 |
| Race and Ethnicity Not Collected(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| United States | 25 | 25 | 24 | 74 |
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University of Kansas Medical Center