Procjena Postoperativne Boli Konvencionalnom i Tumescentnom Anestezijom u Laserskom Tretmanu Pilonidalnog Sinusa
| Registry | NCT07408414 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Opća županijska bolnica Požega (Other) |
| Conditions | Pilonidal Cyst and Sinus Without Abscess, Pilonidal Sinus Disease, Pilonidal Sinus Treatment, Laser Ablation |
| Interventions | local anesthesia using 2% lidocaine, SiLaC, Questionnaire and physical examination, Tumescent local anesthesia (Drug, device, other) |
| Dates | start 2025-09-04, primary completion 2026-09-30 (estimated), completion 2027-09-30 (estimated), first posted 2026-02-13, last updated 2026-02-13 |
| Locations | 1 site in Croatia |
Related Papers Related Patents Related Grants Related Experts
All trials for Pilonidal Cyst and Sinus Without Abscess All trials for Pilonidal Sinus Disease All trials of local anesthesia using 2% lidocaine All trials of SiLaC
"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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Conventional local anesthesia for SiLaC | Active comparator | Drug: local anesthesia using 2% lidocaine; Device: SiLaC; Other: Questionnaire and physical examination | Local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale. |
| Tumescent local anesthesia for SiLaC | Active comparator | Device: SiLaC; Other: Questionnaire and physical examination; Drug: Tumescent local anesthesia | Tumescent local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Opća županijska bolnica Požega | Požega | Croatia | Recruiting |