Beyond Liposuction: Evolving Applications for Tumescent Anesthesia.
C Hanke, Michael Dent
https://pubmed.ncbi.nlm.nih.gov/35005857Actively Recruiting
Led by Opća županijska bolnica Požega · Updated on 2026-02-13
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
The Effect of Local Anesthesia Techniques on Postoperative Pain After Laser Treatment of Pilonidal Sinus
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
Opća županijska bolnica Požega
Požega, Croatia, 34000
Actively Recruiting
G
Gabriela Katharina Pomper, MD PhD
F
Ferdinand Slišurić, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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