Post Operative Pain and Vagal Stimulation

Anorectal surgery is a type of surgery that can cause anal pain, particularly in thecontext of hemorrhoid surgery or anal fissure surgery. Generally, the period ofdiscomfort 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. Itsease of use makes it a promising tool for treating pain. Vagal auricular stimulationcould be an interesting option in the management of postoperative pain of the anus andrectum. 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 theextend of pain reduction associated with perioperative nerve vagus stimulation by amedical device (Transcutaneous Electrical Nerve Stimulator (TENS ECO Plus)). It isoffered to adult patients undergoing transanal anal or rectal surgery on an outpatient orinpatient basis as part of a scheduled procedure.Patients to be included in the study are selected during the initial pre‐operativeconsultation with the surgeon. Once the surgical indication is confirmed and the patientfulfills the study eligibility criteria, the investigator provides them with oralinformation about the study. The patient is also given an information sheet (written inlanguage understandable to the patient) and a consent form.During this initial visit, demographic data and information regarding the surgicalindication are collected.Stimulation begins two days before surgery (twice daily), followed by stimulation on themorning of surgery, one hour before arrival in the operating room. Successful completionof 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 visualanalogue scale (VAS) are collected in the recovery room. Analgesic consumption is alsorecorded.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 patientdiary 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 itspainfulness, as well as any complications related to the stimulation are noted in thepatient diary. On day 3 (+/‐ 2 days) after the procedure, and at the end of the 15‐daypostoperative period, the patient will be contacted by phone or text message by theinvestigator team to remind them to complete the notebook.On day 30 (+/‐ 5 days), the patient returns for a follow‐up visit. The patient diary andequipment are collected. Complications are recorded, as well as quality of life duringthe postoperative month (SF‐36 form).For patients, the expected benefits are significant, as postoperative quality of life isexpected to improve through reduced pain. Furthermore, decreasing the use of step II andIII analgesics should shorten the recovery period and promote better overall recovery.