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Post Operative Pain and Vagal Stimulation

RecruitingNAAges 18 Years - 120 YearsAllUniversity Hospital, Angers
NCT07659314 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 o

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 Exclusion Criteria: * Unscheduled conversion from the transanal route to the abdominal route during surgery
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What it tests

  • Experimental arm
  • Control arm
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Where

1 site
HU Angers
Angers, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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