An interventional study of local anesthesia using 2% lidocaine and SiLaC in Pilonidal Cyst and Sinus Without Abscess, Pilonidal Sinus Disease and Pilonidal Sinus Treatment, sponsored by Opća županijska bolnica Požega. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Opća županijska bolnica Požega · Not applicable, Interventional, and Treatment
"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.
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
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 72 interventional studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →This is the only study on the registry with Opća županijska bolnica Požega as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Device: SiLaC · Other: Questionnaire and physical examination
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 · Other: Questionnaire and physical examination · Drug: Tumescent local anesthesia
Intervention Type: Drug Intervention Name: Lidocaine 2% Description: Conventional local anesthesia using 2% lidocaine infiltrated into the operative field prior to 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.
Intervention Type: Other Intervention Name: Questionnaire and physical examination Description: Postoperative pain evaluation using a visual analog scale (VAS) questionnaire and physical examination.
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.
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
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
Of 35 interventional studies with no phase under Pilonidal Sinus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 12 months is below that.
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