Набор скоро начнётся NCT07659314

Post Operative Pain and Vagal Stimulation

Без фазы С лечением Rectal Surgery Pain (Visceral, Somatic, or Neuropathic) Vagal Nerve Stimulation

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: Experimental arm, Control arm.
Кому может быть актуально: Состояния в реестре: Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic), Vagal Nerve Stimulation. Базовые параметры: 18 лет — 120 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: Франция
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

"Evolution of Postoperative Anal Pain Following Elective Proctological or Rectal Surgery Under the Effect of Transcutaneous Vagal Auricular Stimulation: a Feasibility Study - VAGANAL - Postoperative Pain and Vagal Stimulation"

Обзор

Anorectal surgery is a type of surgery that can cause anal pain, particularly in the context of hemorrhoid surgery or anal fissure surgery. Generally, the period of discomfort related to the pain lasts about two weeks. There is a nerve (the vagus nerve) whose stimulation via a probe placed in the ear can reduce stress and chronic pain. Its ease of use makes it a promising tool for treating pain. Vagal auricular stimulation could be an interesting option in the management of postoperative pain of the anus and rectum. Its efficacy or feasibility in this context has never been evaluated. The aim of this study is to evaluate the feasibility in this context and to assess the extend of pain reduction associated with perioperative nerve vagus stimulation by a medical device (Transcutaneous Electrical Nerve Stimulator (TENS ECO Plus)). It is offered to adult patients undergoing transanal anal or rectal surgery on an outpatient or inpatient basis as part of a scheduled procedure. Patients to be included in the study are selected during the initial pre-operative consultation with the surgeon. Once the surgical indication is confirmed and the patient fulfills the study eligibility criteria, the investigator provides them with oral information about the study. The patient is also given an information sheet (written in language understandable to the patient) and a consent form. During this initial visit, demographic data and information regarding the surgical indication are collected. Stimulation begins two days before surgery (twice daily), followed by stimulation on the morning of surgery, one hour before arrival in the operating room. Successful completion of the stimulation, as well as any complications, are recorded in the patient diary. On the day of surgery (day 0), data concerning the procedure and the maximum visual analogue scale (VAS) are collected in the recovery room. Analgesic consumption is also recorded. On the evening of the procedure, stimulation is performed and adherence is recorded. Maximum and mean VAS are collected on postoperative day 1 and then daily in the patient diary for 15 days. Vagus nerve stimulation is performed morning and evening for 15 days. VAS scores, adherence, analgesic consumption, the date of the first bowel movement and its painfulness, as well as any complications related to the stimulation are noted in the patient diary. On day 3 (+/- 2 days) after the procedure, and at the end of the 15-day postoperative period, the patient will be contacted by phone or text message by the investigator team to remind them to complete the notebook. On day 30 (+/- 5 days), the patient returns for a follow-up visit. The patient diary and equipment are collected. Complications are recorded, as well as quality of life during the postoperative month (SF-36 form). For patients, the expected benefits are significant, as postoperative quality of life is expected to improve through reduced pain. Furthermore, decreasing the use of step II and III analgesics should shorten the recovery period and promote better overall recovery.

Вмешательства

Устройство Experimental arm
active vagus nerve stimulation
Устройство Control arm
no active vagus nerve stimulation

Первичные конечные точки

Change of pain after perioperative auricular vagus nerve stimulation [Срок оценки: day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15]
consumption of analgesic [Срок оценки: From Day 0 to Day 15]

Вторичные конечные точки (4)

Delay in gastrointestinal motility recovery (passage of stool) and post-defecatory pain [Срок оценки: from day 0 to day 30]
Quality of life of patients after surgery [Срок оценки: Day 30]
adverse events [Срок оценки: day 30]
acceptability of perioperative auricular vagus nerve stimulation by the patient [Срок оценки: day 15]

Критерии участия

Критерии включения

Adult patient
Underwent anal or rectal surgery via the transanal route
Managed on an outpatient basis or in conventional hospitalization
Having signed a consent to participate in the study

Критерии исключения

Patient operated on as an emergency
Rectal surgery via abdominal approach or requiring an abdominal approach during the procedure
Known epileptic patient
Patient with a pacemaker
Patient refusing to participate in the study
Pregnant, breastfeeding, or laboring woman
Patient not affiliated with a social security scheme
Person deprived of liberty by judicial or administrative decision
Person subject to compulsory psychiatric care - Any contraindication mentioned in the instructions for use of the medical device under investigation