NCT04985695 Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
| NCT ID | NCT04985695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional Metz-Thionville |
| Condition | Laparotomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-10-11 |
| Primary Completion | 2028-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2021-10-11 with a primary completion date of 2028-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Antoine BECRET, MD
PRINCIPAL INVESTIGATOR
CHR Metz Thionville Hopital de Mercy
Frequently Asked Questions
Who can join the NCT04985695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laparotomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04985695 currently recruiting?
Yes, NCT04985695 is actively recruiting participants. Contact the research team at arpine.el-nar@chr-metz-thionville.fr for enrollment information.
Where is the NCT04985695 trial being conducted?
This trial is being conducted at Metz, France, Thionville, France.
Who is sponsoring the NCT04985695 clinical trial?
NCT04985695 is sponsored by Centre Hospitalier Régional Metz-Thionville. The principal investigator is Antoine BECRET, MD at CHR Metz Thionville Hopital de Mercy. The trial plans to enroll 110 participants.