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

NCT07408414 | Recruiting

• 1 other identifier: Ur. broj: 02-7/3-3/2-2-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

"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.

Conditions

Pilonidal Sinus Disease; Pilonidal Sinus Treatment; Laser Ablation; Pilonidal Cyst and Sinus Without Abscess

Keywords

PSD; Tumescent local anesthesia; Pilonidal sinus; Sinus laser-assisted closure; Tumescent technique; Laser treatment; Laser therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 to 48 hours after surgery

Study Arms (2)

Conventional local anesthesia for SiLaC

ACTIVE COMPARATOR

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 for SiLaC

ACTIVE COMPARATOR

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

Interventions

local anesthesia using 2% lidocaine DRUG

Intervention Type: Drug Intervention Name: Lidocaine 2% Description: Conventional local anesthesia using 2% lidocaine infiltrated into the operative field prior to SiLaC.

Conventional local anesthesia for SiLaC

SiLaC DEVICE

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.

Conventional local anesthesia for SiLaC; Tumescent local anesthesia for SiLaC

Questionnaire and physical examination OTHER

Intervention Type: Other Intervention Name: Questionnaire and physical examination Description: Postoperative pain evaluation using a visual analog scale (VAS) questionnaire and physical examination.

Conventional local anesthesia for SiLaC; Tumescent local anesthesia for SiLaC

Tumescent local anesthesia DRUG

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.

Tumescent local anesthesia for SiLaC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed pilonidal sinus disease
• Laser treatment for pilonidal sinus disease
• Able to provide informed consent

You may not qualify if:

• Recurrent pilonidal sinus
• Chronic pain syndrome
• Prisoners

Sponsors & Collaborators

• Opća županijska bolnica Požega: lead

Study Sites (1)

Opća županijska bolnica Požega

Požega, 34000, Croatia

RECRUITING

Related Publications (4)

• Hanke C, Dent M. Beyond Liposuction: Evolving Applications for Tumescent Anesthesia. J Drugs Dermatol. 2022 Jan 1;21(1):86-89. doi: 10.36849/JDD.2022.6279.

  PMID: 35005857 BACKGROUND

• Uttamani RR, Venkataram A, Venkataram J, Mysore V. Tumescent Anesthesia for Dermatosurgical Procedures Other Than Liposuction. J Cutan Aesthet Surg. 2020 Oct-Dec;13(4):275-282. doi: 10.4103/JCAS.JCAS_192_19.

  PMID: 33911407 BACKGROUND

• Dessily M, Dziubeck M, Chahidi E, Simonelli V. The SiLaC procedure for pilonidal sinus disease: long-term outcomes of a single institution prospective study. Tech Coloproctol. 2019 Dec;23(12):1133-1140. doi: 10.1007/s10151-019-02119-2. Epub 2019 Nov 26.

  PMID: 31773347 BACKGROUND

• Horesh N, Meiri H, Anteby R, Zager Y, Maman R, Carter D, Meyer R, Nachmany I, Ram E. Outcomes of Laser-Assisted Closure (SiLaC) Surgery for Chronic Pilonidal Sinus Disease. J Laparoendosc Adv Surg Tech A. 2023 Jun;33(6):556-560. doi: 10.1089/lap.2022.0567. Epub 2023 Mar 9.

  PMID: 36888964 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Lidocaine; Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Gabriela Katharina Pomper, MD PhD

CONTACT

+38 34 254 532; gabrielakatharina.pomper@pozeska-bolnica.hr

Ferdinand Slišurić, MD

CONTACT

+38 34 254 405

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist for plastic, reconstructive and aesthetic surgery

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: February 13, 2026
• Study Start: September 4, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)