Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07408414

Assessment of Postoperative Pain Using Conventional and Tumescent Local Anesthesia in Laser Treatment of Pilonidal Sinus Disease

Led by Opća županijska bolnica Požega · Updated on 2026-02-13

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are comparing two local anesthesia methods to see their effect on pain after laser treatment for pilonidal sinus disease, a common condition affecting about 2% of the population, mostly men. The study aims to find out if there is a difference in pain levels after surgery using conventional local anesthesia or tumescent local anesthesia, which may provide longer pain relief and reduce bleeding. This is a prospective, randomized study taking place from September 2025 to August 2027 at a general hospital. Participants receive either conventional local anesthesia with 2% lidocaine injected into the surgical area or tumescent local anesthesia, which is a diluted anesthetic solution including lidocaine, epinephrine, and sodium bicarbonate, injected under the skin before laser treatment using a 1470-nm radial-emitting laser fiber. Both groups undergo the same laser treatment for pilonidal sinus. Randomization is done by sealed envelopes prior to surgery. Participants will have their pain assessed using a visual analog scale (VAS) before surgery and on the first, second, and seventh days after surgery. Data on pain scores and demographics will be collected anonymously and assessed without bias. The main outcome measured is pain on the first day after surgery. The study ensures voluntary participation with informed consent, and no additional risks beyond standard care are expected.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed pilonidal sinus disease
  • Scheduled for laser treatment of pilonidal sinus
  • Able to provide informed consent
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Recurrent pilonidal sinus
  • Chronic pain syndrome
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive local anesthesia (either conventional or tumescent) followed by laser treatment for pilonidal sinus disease. Postoperative pain is assessed using a visual analog scale.

1 visit (in-person)

Follow-up

Duration - 7 days

Participants report postoperative pain using the visual analog scale on days 1, 2, and 7 after surgery.

3 visits (in-person or remote) for pain assessment on days 1, 2, and 7

Trial Site Locations

Total: 1 location

1

Opća županijska bolnica Požega

Požega, Croatia, 34000

Actively Recruiting

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Research Team

G

Gabriela Katharina Pomper, MD PhD

F

Ferdinand Slišurić, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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