Roller microneedles transdermal delivery of compound lidocaine cream for enhancing the analgesic effect: A randomized self‐controlled trial
Authors: Hu Hanlin , Guo Lei , He Wanyue , Zhang Hengshu , Xiang Ying , Liu Xianqun , Zou Jing , Du Xuemei , Yan Chun 
Published: May 2022

Objective

The purpose of this article is to investigate whether the percutaneous delivery of compound lidocaine cream by roller microneedles can shorten the minimal effective onset time of anesthesia, enhance the intensity of anesthesia and prolong the analgesic time, so as to provide a theoretical basis for exploring a comfortable, safe and effective anesthesia method for photoelectric cosmetic surgery.

Methods

A total of 90 healthy volunteers, including 18 male and 72 female, met the criteria and were enrolled in the study from December 2020 to September 2021 in Department of Plastic and Burn Surgery of the First Affiliated Hospital of Chongqing Medical University. This study adopted a two‐factor randomized block design of 3 (anesthesia time on the test side: 30, 45, 60 min) × 2 (the test side: the left and right side), and the subjects were divided into group A (n = 30), group B (n = 30), and group C (n = 30). On the test side, the compound lidocaine cream was used for topic anesthesia for 10 min, then the roller microneedle was used to roll on the treatment area, compound lidocaine cream was appropriately supplemented, and the topic anesthesia was kept continued for 20 min (group A), 35 min (group B), and 50 min (group C), respectively. The mirrorsymmetrical area of the test side of the three groups was the control side, and the compound lidocaine cream was used for topic anesthesia for 60 min. Photoelectric therapy was performed after anesthesia was completed. The analgesic effect of the subjects on both sides was comprehensively compared; the scores were obtained using the Kuttner Facial Expression Scale, the Frankl Treatment Compliance Scale, the Houpt Behavior Scale, and the Visual Analog Scale (VAS); the satisfaction with anesthesia was investigated. Before and after treatment the skin temperature, color and adverse reactions of the subjects were recorded.

Results

Comparing both sides of the same group, there was no significant difference in terms of the comprehensive evaluation, intraoperative comfort, tolerance, cooperation, pain or satisfaction between the 30‐min test side and the routine anesthesia side in group A; the comprehensive evaluation, intraoperative tolerance, cooperation degree, pain degree and satisfaction evaluation of the subjects on the 45‐min test side in group B were significantly better than those on the control side; the comprehensive evaluation, intraoperative comfort, tolerance, cooperation, pain and satisfaction of the subjects on the 60‐min test side in group C were significantly better than those on the control side. Comparing groups on the control side, there was no significant difference in the comprehensive evaluation, intraoperative comfort, tolerance, cooperation, pain or satisfaction between the three groups of subjects on the control side. Comparing the three groups on the test side, with the prolongation of compound lidocaine cream indwelling time, the subjects' comprehensive evaluation, comfort and pain degree were significantly improved. There was no significant difference in postoperative bruising, swelling, pain, discoloration, redness, or tenderness between the test side and the control side.

Conclusion

The percutaneous delivery of compound lidocaine cream by roller microneedles can not only shorten the effective time of anesthesia, but also has a good analgesic effect without obvious adverse reactions.