Bupivacaine Implant May Improve Pain Outcomes After Abdominoplasty

Compared with placebo, a bupivacaine implant provided more postoperative analgesic effects in the first 24 hours following abdominoplasty, according to findings from a multicenter, randomized, double-blind, placebo-controlled trial (NCT04785625), published in Regional Anesthesia & Pain Medicine.

The implant, INL-001, was approved by the US Food and Drug Administration for inguinal hernia repair and comprises a collagen-matrix drug-delivery implant with bupivacaine hydrochloride.

Researchers identified 366 patients undergoing elective abdominoplasty with rectus sheath plication and randomly assigned them to receive 3 implants with 100 mg bupivacaine each (n=181; 100% women) or placebo (n=184; 98.4% women), to be inserted prior to incision closure.

The intervention and control cohort group had a mean age of 43.3 (SD, 9.0) and 43.1 (SD, 9.0) years; a mean BMI of 27.4 (SD, 3.1) and 27.6 (SD, 2.8) kg/m²; 71.8% and 69.6% were White; and 99.4% and 99.5% had successful placement of all 3 implants, respectively.

Postsurgical pain intensity was evaluated using an 11-point Numerical Pain Rating Scale and the sum of pain intensity (SPI) score was calculated from placement of the implants to 24 (SPI24), 48 (SPI48), and 72 (SPI72) hours.

Patients who received INL-001 reported lower SPI24 scores compared with placebo recipients (P =.002), but did not report significantly lower SPI48 scores (P >.05).

As SPI48 scores were not significant, all other secondary efficacy outcomes were deemed as nonsignificant. However, the INL-001 recipients tended to report lower SPI72 scores (mean, 264.60 vs 281.10) and more were opioid-free at 24 (18.8% vs 6.5%), 48 (17.1% vs 6.5%), and 72 (17.1% vs 6.5%) hours compared with placebo, respectively.

The most common adverse event reported was back pain (7.7%).

One limitation of this study was that no active comparator was used. In addition, the authors acknowledged that the majority of patients included in the trial were women; however, this is representative of the average abdominoplasty surgery patient population.

“Treatment with INL-001 was well tolerated in this patient population, with no evidence of systemic bupivacaine toxicity or impaired wound healing,” the study authors noted. “These results may support expanding the indication of INL-001 for use in soft tissue surgeries beyond inguinal hernia repair,” they concluded.

Disclosures: This research was supported by Innocoll Pharmaceuticals. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.