Comparing two local anesthesia methods for pain after laser treatment of pilonidal sinus
Procjena Postoperativne Boli Konvencionalnom i Tumescentnom Anestezijom u Laserskom Tretmanu Pilonidalnog Sinusa
NA · Opća županijska bolnica Požega · NCT07408414
This study will see if standard lidocaine injections or tumescent local anesthesia causes less postoperative pain for people having laser treatment for pilonidal sinus disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Opća županijska bolnica Požega (other) |
| Locations | 1 site (Požega) |
| Trial ID | NCT07408414 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized comparison of conventional local anesthesia (2% lidocaine infiltration) versus tumescent local anesthesia given during SiLaC (sinus laser-assisted closure) for pilonidal sinus disease. Pain scores will be recorded on postoperative day 1, day 2, and at one week, along with analgesic use and clinical follow-up. Adults with primary pilonidal sinus scheduled for laser ablation and able to give informed consent will be enrolled at General County Hospital Požega. Patients with recurrent disease, chronic pain syndrome, or other exclusions will be omitted to keep the comparison focused on primary cases.
Who should consider this trial
Good fit: Adults with a new (nonrecurrent) pilonidal sinus disease who are scheduled for SiLaC laser ablation and can provide informed consent are appropriate candidates.
Not a fit: People with recurrent pilonidal disease, chronic pain syndromes, prisoners, or those who require or prefer spinal/general anesthesia are unlikely to benefit from the study comparison.
Why it matters
Potential benefit: If successful, the preferred anesthesia method could reduce early postoperative pain, lower pain medication needs, and support quicker recovery after outpatient laser treatment.
How similar studies have performed: Prior reports suggest local anesthesia reduces early postoperative pain and tumescent techniques prolong analgesia in other procedures, but direct randomized comparisons specifically for SiLaC are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Požega
- Opća županijska bolnica Požega — Požega, Croatia (RECRUITING)
Study contacts
- Study coordinator: Gabriela Katharina Pomper, MD PhD
- Email: gabrielakatharina.pomper@pozeska-bolnica.hr
- Phone: +38 34 254 532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pilonidal Cyst and Sinus Without Abscess, Pilonidal Sinus Disease, Pilonidal Sinus Treatment, Laser Ablation, PSD, Tumescent local anesthesia, Pilonidal sinus, Sinus laser-assisted closure