BACKGROUND:Pain during and after implantation of dermal gel fillers is a consistent complaint of patients undergoing soft tissue augmentation. Reduction of pain during injection would increase patient comfort and improve the overall patient experience. OBJECTIVE: To evaluate pain at the injection site during and after the injection of Prevelle SILK or Captique and to evaluate outcomes after 2 weeks. METHODS & MATERIALS: In a patient-blinded, prospective, randomized, split-face design trial, a non-animal-derived hyaluronic acid based filler formulated with lidocaine (Prevelle SILK) was injected in one nasolabial fold (NLF), and the same filler without lidocaine (Captique) was injected in the contralateral NLF of 45 enrolled patients. Injection site pain was measured using a visual analogue scale at injection (time 0) and 15, 30, 45, and 60 minutes after injection. Patients were asked to return for an evaluation after 2 weeks and to complete a self-assessment questionnaire during the follow-up visit. RESULTS: There was more than 50% less pain associated with the dermal gel with lidocaine than with the same filler without lidocaine at all time points (p<.05). The greatest difference in pain was recorded at the time of injection, and then the effect gradually declined over the 60-minute period. Both fillers were well tolerated, and there was no difference in outcome after 2 weeks. CONCLUSION: Addition of lidocaine to a filler resulted in significantly less pain associated with the procedure without compromising outcomes.
RCT Entities:
BACKGROUND:Pain during and after implantation of dermal gel fillers is a consistent complaint of patients undergoing soft tissue augmentation. Reduction of pain during injection would increase patient comfort and improve the overall patient experience. OBJECTIVE: To evaluate pain at the injection site during and after the injection of Prevelle SILK or Captique and to evaluate outcomes after 2 weeks. METHODS & MATERIALS: In a patient-blinded, prospective, randomized, split-face design trial, a non-animal-derived hyaluronic acid based filler formulated with lidocaine (Prevelle SILK) was injected in one nasolabial fold (NLF), and the same filler without lidocaine (Captique) was injected in the contralateral NLF of 45 enrolled patients. Injection site pain was measured using a visual analogue scale at injection (time 0) and 15, 30, 45, and 60 minutes after injection. Patients were asked to return for an evaluation after 2 weeks and to complete a self-assessment questionnaire during the follow-up visit. RESULTS: There was more than 50% less pain associated with the dermal gel with lidocaine than with the same filler without lidocaine at all time points (p<.05). The greatest difference in pain was recorded at the time of injection, and then the effect gradually declined over the 60-minute period. Both fillers were well tolerated, and there was no difference in outcome after 2 weeks. CONCLUSION: Addition of lidocaine to a filler resulted in significantly less pain associated with the procedure without compromising outcomes.
Authors: Tomasz Stefura; Artur Kacprzyk; Jakub Droś; Marta Krzysztofik; Oksana Skomarovska; Marta Fijałkowska; Mateusz Koziej Journal: Aesthetic Plast Surg Date: 2021-07-13 Impact factor: 2.708