Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
Recruiting now · Not applicable
Conditions studied: Laparotomy
In brief
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.
Key facts
- Study ID
- NCT04985695
- Run by
- Centre Hospitalier Régional Metz-Thionville
- People needed
- 110
- Starts
- 2021-10-11
- Expected to finish
- 2029-04-10
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHR Metz Thionville Hopital de Mercy — Metz, Moselle, France (enrolling)
- CHR Metz-Thionville Hopital Bel Air — Thionville, France
Full record on ClinicalTrials.gov
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