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