RecruitingNot Applicable

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

France110 participantsStarted 2021-10-11

Plain-language summary

Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy * Have given an informed written consent * Able to read and understand french language * Affiliation to a social security system Exclusion Criteria: * Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder), * Epidural analgesia contraindication * With impossibility to set up bilateral rectus sheath block * Participation in another clinical study * Pregnant women * Patients deprived of their liberty by a judicial or administrative decision, * Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in total QoR-15 score

Timeframe: Postoperative day 2

Trial details

NCT IDNCT04985695

SponsorCentre Hospitalier Régional Metz-Thionville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10-10

Contact for this trial

Arpiné EL NAR, PhD

0033387557766 arpine.el-nar@chr-metz-thionville.fr

View on ClinicalTrials.gov More Laparotomy trials