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

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorOpća županijska bolnica Požega

About this trial

"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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed pilonidal sinus disease

Laser treatment for pilonidal sinus disease

Able to provide informed consent

Disqualifiers

Recurrent pilonidal sinus

Chronic pain syndrome

Prisoners

Trial design

Design model

Parallel

Treatments tested in this trial

local anesthesia using 2% lidocaine
Drug
Intervention Type: Drug Intervention Name: Lidocaine 2% Description: Conventional local anesthesia using 2% lidocaine infiltrated into the operative field prior to SiLaC.
SiLaC
Device
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.
Questionnaire and physical examination
Other intervention
Intervention Type: Other Intervention Name: Questionnaire and physical examination Description: Postoperative pain evaluation using a visual analog scale (VAS) questionnaire and physical examination.
Tumescent local anesthesia
Drug
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Conventional local anesthesia for SiLaCActive comparator 3 interventions

Group B: Tumescent local anesthesia for SiLaCActive comparator 3 interventions

Trial outcomes

Primary outcomes

Pain score VAS - Day 1

VAS (visual analog scale for pain) value obtained via questionnaire on day 1 after the operation.The VAS score has a scale of 1-10, where 1 represents completely pain-free and 10 represents the strongest imaginable pain.

Time frame

24 to 48 hours after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Opća županijska bolnica Požega

Lead sponsor

Source ClinicalTrials.gov

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