Table 4 Summary of studies assessing the efficacy of bupivacaine-loaded lipid nanoparticle
Author | Study design | Surgery | Intervention/Placebo | Primary end point | Results |
|---|---|---|---|---|---|
Gorfine et al. [54] | Random controlled trial | Hemorrhoidectomy | DepoFoam Bupivacaine 300 mg compared with 0.9 % sodium chloride | Numerical rating score (NRS), AUC 0–72 h | Pain intensity scores were significantly decreased in the extended release bupivacaine group versus placebo (141.8 vs. 202.5, P < 0.001). |
Smoot et al. [55] | Random controlled trial | Mammoplasty | DepoFoam bupivacaine 600 mg compared with bupivacaine HCL 200 mg þ epinephrine 1:200,0000 | NRS-Activity, AUC 0–72 h | No statistical difference between the groups (AUC NRS-A, 441 vs. 468, P 1⁄4 0.3999). |
Golf et al. [29] | Random controlled trial | Bunionectomy | DepoFoam 120 mg compared to 0.9 % sodium chloride | NRS AUC 0–24 h | Pain intensity score was significantly decreased in lipid nanoparticle bupivacaine versus control, 123.9 in DepoFoam versus 146 in placebo, P < 0.0005. |
Bramlett et al. [28] | Random controlled trial | Total knee arthroplasty | DepoFoam bupivacaine (133, 266, 399, and 532 mg) compared to bupivacaine HCl 150 mg with epinephrine 1:200,000 | NRS-A, AUC 0–96 h | No statically significant difference between all DepoFoam groups versus bupivacaine HCl (P > 0.05). |
Cohen et al. [56] | Cohort study | Colectomy | DepoFoam 366 mg compared with postoperative PCA | Total milligrams of opioids consumed after surgery and total cost of hospitalization | Mean total amount of postsurgical opioids significantly less in DepoFoam compared to PCA group (57 vs. 115 mg, P 1⁄4 0.025). Average cost of hospitalization significantly less in DepoFoam versus PCA (US$ 8766 vs. US$ 11,850 P 1⁄4 0.027). |