RecruitingNot ApplicableNCT07408414

The Effect of Local Anesthesia Techniques on Postoperative Pain After Laser Treatment of Pilonidal Sinus

Procjena Postoperativne Boli Konvencionalnom i Tumescentnom Anestezijom u Laserskom Tretmanu Pilonidalnog Sinusa


Sponsor

Opća županijska bolnica Požega

Enrollment

100 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

"Assessment of postoperative pain with conventional and tumescent local anesthesia in the laser treatment of pilonidal sinus." The aim of this study is to: examine the possible difference in postoperative pain between two local anesthesia procedures after laser treatment of pilonidal sinus disease on the first and second postoperative day, as well as one week after surgery. During the procedure, two well-established anesthesia techniques are used to make the surgical area painless. The first is local anesthesia, in which the anesthetic is injected into and under the skin. The second procedure is tumescent anesthesia. In this procedure, the anesthetic in diluted form is introduced into the subcutaneous tissue. Both procedures are used in surgery and are standard methods of local anesthesia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Questionnaire and physical examination, a medical device called SiLaC, and others for people with laser ablation, pilonidal cyst and sinus without abscess, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGlocal anesthesia using 2% lidocaine

Intervention Type: Drug Intervention Name: Lidocaine 2% Description: Conventional local anesthesia using 2% lidocaine infiltrated into the operative field prior to SiLaC.

DEVICESiLaC

Intervention Type: Device Intervention Name: 1470-nm radial-emitting laser fiber (SiLaC) Description: Thermal ablation of pilonidal sinus tracts using a 1470-nm radial-emitting laser fiber (1470 nm) with power adjusted between 8 and 10 Watt.

OTHERQuestionnaire and physical examination

Intervention Type: Other Intervention Name: Questionnaire and physical examination Description: Postoperative pain evaluation using a visual analog scale (VAS) questionnaire and physical examination.

DRUGTumescent local anesthesia

Intervention Type: Drug Intervention Name: Tumescent local anesthetic solution Description: Tumescent solution prepared with 500 mL normal saline, 20 mL 2% lidocaine, one ampule of epinephrine (1 mg/mL), and 5 mL sodium bicarbonate; infiltrated into the operative field prior to SiLaC.


Locations(1)

Opća županijska bolnica Požega

Požega, Croatia

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NCT07408414


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