Effect Of Electroacupuncture With Local Anesthesia On Pain And Stress During Impacted Lower Third Molar Surgery

Официальное название

Effect Of Electroacupuncture As An Adjunct To Local Anesthesia On Perioperative Pain And Stress During Ambulatory Surgical Extraction Of Impacted Lower Third Molars

Обзор

This randomized controlled trial investigates the effect of electroacupuncture as an adjunct to local anesthesia on perioperative pain and stress during ambulatory surgical extraction of impacted lower third molars. Participants will be randomized into three groups: electroacupuncture, sham acupuncture, and control. Pain intensity and perceived stress will be assessed using validated scales, while biological stress and nociceptive markers (salivary cortisol, alpha-amylase, and substance P), as well as hemodynamic parameters (blood pressure and heart rate), will be measured. The study aims to provide an integrated evaluation of the effects of electroacupuncture on subjective, biological, and physiological indicators of perioperative response in oral surgery.

Подробное описание

Perioperative pain and stress during surgical extraction of impacted lower third molars remain clinically relevant despite the use of local anesthesia. Psychological factors such as dental anxiety and physiological stress responses contribute to variability in pain perception and perioperative outcomes. Electroacupuncture has been proposed as a non-pharmacological adjunct that may modulate both nociceptive and stress-related pathways through neurohumoral mechanisms, including endogenous opioid release and autonomic regulation.

This prospective randomized controlled trial is designed to evaluate the effect of electroacupuncture as an adjunct to local anesthesia on perioperative response in patients undergoing ambulatory surgical extraction of impacted lower third molars. The study incorporates a three-arm parallel design, including electroacupuncture, sham acupuncture, and standard care without acupuncture, allowing differentiation between specific and non-specific effects of the intervention.

An integrated assessment approach will be used to capture multiple dimensions of the perioperative response, including subjective, biological, and physiological components. This design enables a comprehensive evaluation of the interaction between stress, autonomic activation, and nociceptive processing in a standardized oral surgery model. The findings are expected to contribute to the understanding of the clinical value of electroacupuncture as an adjunctive modality in perioperative care.

Вмешательства

• Процедура Electroacupuncture
  Electroacupuncture is applied for 15 minutes prior to local anesthesia using a standardized protocol with selected acupuncture points. Electrical stimulation is delivered via a digital electroacupuncture device at an individually adjusted intensity to produce a clear but non-painful sensation.
• Процедура Sham Acupuncture
  Sham acupuncture consists of superficial needle insertion at non-acupuncture points without electrical stimulation or needle manipulation. The procedure mimics the active intervention in duration and setting but is designed to have no therapeutic effect.

Первичные конечные точки

• Perioperative Pain Intensity [Срок оценки: Baseline and 30 minutes after surgical extraction]

Вторичные конечные точки (7)

• Perceived Stress [Срок оценки: Baseline and 30 minutes after surgical extraction]
• Salivary Cortisol Levels [Срок оценки: Baseline and 30 minutes after surgical extraction]
• Salivary Alpha-Amylase Levels [Срок оценки: Baseline and 30 minutes after surgical extraction]
• Salivary Substance P Levels [Срок оценки: Baseline and 30 minutes after surgical extraction]
• Systolic Blood Pressure [Срок оценки: Baseline and immediately after surgical extraction]
• Diastolic Blood Pressure [Срок оценки: Baseline and immediately after surgical extraction]
• Heart Rate [Срок оценки: Baseline and immediately after surgical extraction]

Критерии участия

Критерии включения

• Adults aged 25-35 years
• ASA physical status I-II
• Indication for ambulatory surgical extraction of an impacted lower third molar
• Ability to understand the study procedures and provide written informed consent
• Willingness to comply with study procedures, including saliva sampling protocol
• Ability to abstain from food, beverages, and oral hygiene procedures for at least 1 hour prior to saliva sampling

Критерии исключения

• Pregnancy
• Epilepsy
• Presence of a pacemaker or other active electronic implant
• Coagulation disorders
• Active infection at the site of acupuncture
• Systemic inflammatory diseases
• Oral inflammatory conditions (e.g., gingivitis or periodontitis)
• Hyposalivation
• Chronic opioid use
• Psychiatric conditions that may affect pain or stress assessment
• Use of nonsteroidal anti-inflammatory drugs, corticosteroids, or antibiotics within 7 days prior to the procedure
• Menstruation at the time of saliva sampling
• Inability or unwillingness to comply with study procedures

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Хорватия · 1 центр

• University Hospital Dubrava — Zagreb

Идентификаторы

NCT: NCT07509294 · 003-01/26-05/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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