Local Anesthesia Strategies in SiLaC Laser Pilonidal Sinus Treatment: Early Postoperative Pain Outcomes in a Device Trial

Published February 15, 2026. A regulatory minded update examines anesthesia methods used during laser treatment of pilonidal sinus. The trial uses the SiLaC device for laser ablation in pilonidal cyst and sinus disease without abscess. Interventions include local anesthesia using 2 percent lidocaine and tumescent local anesthesia, with a structured questionnaire and physical examination to capture early postoperative pain and patient experience. The sponsor is Opća županijska bolnica Požega. Registry status is listed as recruiting in the public trial registry as of the posting date. The official trial registry entry can be accessed at ClinicalTrials.gov NCT07408414, which provides the formal description of the device, population and endpoints. Clinicians, device developers, and regulators may find these comparisons relevant when evaluating pain management in laser based pilonidal sinus treatment. For readers seeking context, related regulatory coverage can be found in Pilonidal Sinus SiLaC regulatory update and Local anesthesia in device trials overview.

What changed in the trial design

The update centers on anesthesia choices used with a modern laser removal approach for pilonidal sinus conditions. The technique studied uses SiLaC for laser ablation of pilonidal tissue in non abscess sinus. The trial compares two local anesthesia strategies: 2 percent lidocaine and tumescent local anesthesia, administered per standard practice. A standardized questionnaire and physical examination document pain intensity, time to first analgesic use, and functional recovery following the procedure. The population includes pilonidal cyst and sinus disease without abscess, aligning with non infectious presentations. The trial aims to determine whether anesthesia technique influences early postoperative pain, patient satisfaction, and immediate safety signals after a device based intervention.

What can 2 percent lidocaine offer in this context?

2 percent lidocaine is a widely used local anesthetic for minor procedures. In this trial it provides intraoperative analgesia for SiLaC laser ablation. The aim is to minimize early pain while preserving safety. Data collection includes a patient pain questionnaire and clinical checks during recovery.

What is the tumescent approach and why is it included?

Tumescent anesthesia uses a dilute anesthetic solution in a large tissue volume that expands the tissue plane and reduces discomfort and bleeding. In this trial it is evaluated as an alternative to standard lidocaine injections for laser pilonidal sinus treatment. This approach may improve patient comfort and reduce the need for systemic analgesia. The trial records safety signals and any adverse events through a structured examination and patient reporting.

What regulatory context applies to this device trial?

Regulatory considerations include ensuring the procedure aligns with device labeling and intended use for laser ablation of pilonidal sinus with the SiLaC device. Local anesthesia methods form part of the patient safety plan and influence risk management documentation. The trial contributes evidence about performance and safety that could affect future labeling guidance and clinician practice. The sponsor’s involvement signals institutional oversight and compliance with applicable clinical trial regulations. The public registry enhances transparency for patients and clinicians.

What could this mean for patient care and practice?

If the anesthesia method demonstrates a clear difference in pain outcomes, clinicians may favor one approach for this procedure to improve comfort after laser treatment. Regulators may consider how such findings influence labeling, training, and post market surveillance. This is particularly relevant for device based therapies used in pilonidal sinus disease and related conditions.

Conclusion and implications for readers

The trial framework demonstrates a clear focus on how anesthesia methods may influence pain and recovery after laser treatment for pilonidal sinus. Findings may inform clinical practice choices and contribute to the regulatory discourse on device use with anesthesia in pilonidal disease. Readers should track the registry entry for updates and await results that may shape pain management guidance and safety monitoring for laser based pilonidal sinus therapy.