Post Operative Pain and Vagal Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental arm, Control arm.
- Who it may be relevant to
- Registry conditions: Rectal Surgery, Pain (Visceral, Somatic, or Neuropathic), Vagal Nerve Stimulation. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"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"
Overview
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.
Interventions
- Device Experimental arm
active vagus nerve stimulation - Device Control arm
no active vagus nerve stimulation
Primary outcome measures
- Change of pain after perioperative auricular vagus nerve stimulation [Time frame: 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 [Time frame: From Day 0 to Day 15]
Secondary outcome measures (4)
- Delay in gastrointestinal motility recovery (passage of stool) and post-defecatory pain [Time frame: from day 0 to day 30]
- Quality of life of patients after surgery [Time frame: Day 30]
- adverse events [Time frame: day 30]
- acceptability of perioperative auricular vagus nerve stimulation by the patient [Time frame: day 15]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Angers Hospital — Angers
Identifiers
NCT: NCT07659314 · 49RC25-0293 · 2026-A01004-47