Burns, Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLidocaine Hydrochloride
Injected subcutaneously for skin graft harvesting
DRUGLiposomal bupivacaine
Injected subcutaneously for skin graft harvesting
DRUGBupivacaine Hydrochloride
Used for regional nerve block for skin graft harvesting
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only subjects in first phase will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future.
Intervention model description
Phase 1 -randomized pre-operatively to receive either lidocaine or liposomal bupivicaine Phase 2- all enrolled into regional nerve block group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spanish/English speaking * \<20%TBSA; \<5% TBSA deep partial or full thickness burns
Exclusion criteria
* chronic pain syndrome * \> 20% TBSA burn injury; \> 5% TBSA deep partial or full thickness burn * pregnant * allergy to lidocaine or other local anesthetics * burns to anterior thighs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Measurement of Post Operative Pain Involving Skin Graft Donor Site Using Visual Analog Scale (VAS) Ranging 0-10, at 8 Hours Post-operatively | The subject completes a pain assessment 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72 hours (3 days) post operatively | Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents |
| Pain Scores Over 72 Hours After Surgery | 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 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants |
| Age, Continuous | 47.88 years STANDARD_DEVIATION 17.31 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 24 |
Outcome results
None listed