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

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.

Conditions

• Pilonidal Cyst and Sinus Without Abscess
• Pilonidal Sinus Disease
• Pilonidal Sinus Treatment
• Laser Ablation

Interventions

DRUG

local 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.

DEVICE

SiLaC

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.

OTHER

Questionnaire 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.

DRUG

Tumescent 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.

Sponsors & Collaborators

• Opća županijska bolnica Požega

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-04

Primary Completion

2026-09-30

Completion

2027-09-30

Countries

• Croatia

Study Locations