Evaluation of Liposomal Bupivacaine at Split Thickness Skin Graft Donor Sites through a Randomized, Controlled Trial

PURPOSE: Split thickness skin grafts are commonly required in reconstructive surgery, particularly in the acute burn population. Donor sites from split thickness skin grafts (STSG) can be painful and in burn patients are often reported to be more painful than the burn injury itself. Liposomal bupivacaine has been described to provide longer lasting surgical site pain relief when compared with traditional local anesthetics, but evaluation of efficacy in treating STSG donor sites has been limited. The goal of this investigator initiated randomized, controlled clinical trial is to evaluate the effect of liposomal bupivacaine compared with standard of care on donor site pain and opioid consumption. MATERIALS AND METHODS: A parallel, randomized, single-center controlled trial of adult acute burn patients with <20% total body surface area burns was conducted to evaluate the efficacy of liposomal bupivacaine at STSG donor sites. Patients were blinded to group allocation. The control group received standard subcutaneous infiltration of dilute lidocaine solution at the STSG donor site, and the experimental group received dilute liposomal bupivacaine infiltration in a similar fashion. Preoperative pain scores and opioid consumption were evaluated. Donor site scores were assessed at regular intervals for 72 hours postoperatively. Opioid consumption was totaled in morphine equivalents for 24, 48, and 72 hours postoperatively. Sample size was determined by power analysis. Categorical variables were summarized with percentages, and continuous variables were summarized by means and medians. Chi-square test was used for testing associations between categorical variables. T-Test was used to compare means across groups, using ANCOVA to control for preoperative variables when appropriate. RESULTS: A total of 25 patients were enrolled in each group, and 80% of each group were male (n = 20, P = 1.0). Average age was 49.2 (SD 15.9) in the control group and 47.0 (SD17.4) in the experimental group (P = 0.67). In the control group, 72% (n = 18) of patients were white and 20% (n = 5) were black compared with 76% (n = 19) and 12% (n = 3), respectively, in the experimental group (P = 0.55). Average total body surface area burns was 4.0% in both groups (P = 0.94). All donor sites were on the thigh and a standard dressing was used. There were no statistical differences in pain scores at any time point postoperatively (mean control range 3.1/10–4.9/10, experimental range 3.3/10–4.3/10, P = 0.12–0.96). There were no statistical differences in opioid consumption at 24, 48, or 72 hours postoperatively between the groups (mean control morphine equivalents range 49.3–71.1, experimental morphine equivalents range 63.6–75.8, P = 0.34–0.85). The average length of stay was 7.7 days in both groups (P = 0.88). No adverse events occurred in either group. CONCLUSIONS: There is no statistical benefit to the use of liposomal bupivacaine for infiltration at STSG donor sites compared with standard of care with respect to pain control, opioid use, or length of stay when evaluated in a randomized, controlled fashion. Although the product appears safe and equivalent to lidocaine in management of STSG donor sites, the additional cost associated with liposomal bupivacaine does not warrant its use in this setting.

Abstract licence: CC BY-NC-ND

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