The Effect of Local Anesthesia Techniques on Postoperative Pain After Laser Treatment of Pilonidal Sinus
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: local anesthesia using 2% lidocaine, SiLaC, Questionnaire and physical examination, Tumescent local anesthesia.
- Кому может быть актуально
- Состояния в реестре: Pilonidal Cyst and Sinus Without Abscess, Pilonidal Sinus Disease, Pilonidal Sinus Treatment, Laser Ablation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Хорватия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Procjena Postoperativne Boli Konvencionalnom i Tumescentnom Anestezijom u Laserskom Tretmanu Pilonidalnog Sinusa
Обзор
"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.
Подробное описание
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
Вмешательства
- Препарат local anesthesia using 2% lidocaine
Intervention Type: Drug Intervention Name: Lidocaine 2% Description: Conventional local anesthesia using 2% lidocaine infiltrated into the operative field prior to SiLaC. - Устройство SiLaC
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. - Другое Questionnaire and physical examination
Intervention Type: Other Intervention Name: Questionnaire and physical examination Description: Postoperative pain evaluation using a visual analog scale (VAS) questionnaire and physical examination. - Препарат Tumescent local anesthesia
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.
Первичные конечные точки
- Pain score VAS - Day 1 [Срок оценки: 24 to 48 hours after surgery]
Критерии участия
Критерии включения
- Diagnosed pilonidal sinus disease
- Laser treatment for pilonidal sinus disease
- Able to provide informed consent
Критерии исключения
- Recurrent pilonidal sinus
- Chronic pain syndrome
- Prisoners
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Хорватия · 1 центр
- Opća županijska bolnica Požega — Požega
Публикации
- 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
- 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
- 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
- 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
Идентификаторы
NCT: NCT07408414 · Ur. broj: 02-7/3-3/2-2-2025