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

February 10, 2026 updated by: Gabriela Katharina Pomper, Opća županijska bolnica Požega

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

"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Title/topic of the research project:

Assessment of postoperative pain under conventional and tumescent local anesthesia in laser treatment of pilonidal sinus

Type of project/research:

Prospective, randomized study

Location of research:

General County Hospital Požega

Time period of the research:

01/09/2025 - 31/08/2027, or until a sufficient number of participants is collected

Project funding:

Principal investigator

"Explanation of the research topic"

Introduction:

Pilonidal disease is very common - literature states that 2% of the population is affected, in a 2:1 ratio in favor of men. Although not lethal, it significantly reduces quality of life. It can be treated conservatively or surgically. Different anesthesia techniques can be used when preparing patients for surgery, such as local, spinal, and general anesthesia. Pain is one of the most important factors influencing quality of life after surgery. Many attempts have been made to select the most appropriate surgery and anesthesia method to reduce pain during and after surgery.

Research shows that using local anesthesia for pilonidal sinus surgery is associated with reduced pain in the first 48 hours, shorter hospital stay, and lower use of analgesics. Therefore, local anesthesia may be appropriate for outpatient procedures.

Tumescent local anesthesia is a form of local anesthesia that, due to the addition of adrenaline and sodium bicarbonate, causes vasoconstriction and prolonged analgesia and reduces postoperative bleeding. Because of this, tumescent anesthesia is increasingly used in various dermatological and plastic-surgical procedures.

Aim of the research:

To examine possible differences in postoperative pain between two local anesthesia techniques after surgery.

Purpose of the research:

Evaluation of postoperative pain during laser treatment of pilonidal sinus depending on anesthesia technique.

Hypothesis:

There is a significant difference (p < 0.05) on the VAS pain scale (1-10) between the two anesthesia techniques.

Methodology and materials:

All patients treated with laser method for pilonidal sinus disease will have demographic data collected, as well as pain assessment at the surgical site using the VAS scale before surgery and on days 1, 2 and 7 after surgery. Randomization is by sealed envelopes prior to surgery.

"Research plan & participants"

Research plan:

From September 2025 to August 2028, patients who choose laser treatment for pilonidal sinus will be included after signing informed consent. Participation is voluntary. Randomization will be described, a questionnaire completed, and pain will be evaluated on the VAS scale at four time points: preoperative, first, second, and seventh postoperative day. Results will be collected in sealed envelopes and assessed blindly.

Expected scientific contribution:

If a difference exists between the groups, the method with less postoperative pain would be preferred and improve patient satisfaction.

Special notes:

To date, no study has examined these two methods regarding perceived postoperative pain during laser treatment of pilonidal sinus.

PARTICIPANTS

Number of participants:

Approximately one hundred

Inclusion criteria:

Adults with pilonidal sinus able to provide informed consent

Exclusion criteria:

Minors, recurrent pilonidal sinus, patients with chronic pain syndrome, prisoners

"Risks of participating in the research" Are participants minors, people with special needs, psychiatric patients, prisoners, detainees, or persons under investigation? NO Does the research involve a sensitive topic (law violations, sexual abuse, sexual orientation, etc.)? NO Does participation involve alcohol, tobacco, medication, psychoactive substances, or placebo? NO Are participants exposed to potential physical or psychological harm? NO Does the procedure involve exercise or physical activity? NO

Other possible risks:

None Is the research risk minimal? YES

"Participant consent"

Description of how consent is obtained:

Before filling out the questionnaire, the examiner will verbally explain the goal and method of the study. The participant will receive written informed consent and sign approval to participate.

How the research is explained:

Verbally and in writing

Compensation for participants:

/

Possible risks:

None

Protection of participant identity:

Anonymous questionnaire

Confidentiality:

Data will be used only for the research and available only to the researcher. The questionnaire is anonymous and voluntary.

Use of audio/video/electronic recordings:

/

Date and signature of researcher:

28/07/2025

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ferdinand Slišurić, MD
  • Phone Number: +38 34 254 405

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed pilonidal sinus disease
  • Laser treatment for pilonidal sinus disease
  • Able to provide informed consent

Exclusion Criteria:

  • Recurrent pilonidal sinus
  • Chronic pain syndrome
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional local anesthesia for SiLaC
Local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
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.
Active Comparator: Tumescent local anesthesia for SiLaC
Tumescent local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score VAS - Day 1
Time Frame: 24 to 48 hours after surgery
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.
24 to 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Opća županijska bolnica Požega

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ur. broj: 02-7/3-3/2-2-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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