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Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

Recruiting
18 years of age
Both
Phase N/A

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Overview

Randomized controlled trial (1:1) in two parallel groups, monocentric, 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.

Description

Implementation of fast-track rehabilitation surgery was essential in patient care, specially in oncological point.

In this way, uses of the technic of local anesthesia, include epidural analgesia, was essential, but this one is associated with few complications. Emergence of new technic of anesthesia with a comparative analgesia and without side effects should be a better alternative than epidural analgesia. Thus, bilateral rectus sheath block has been reported to be effective in management of postoperative pain.

After signing of the informed consent, two postoperative analgesia techniques were investigated in patients undergoing midline laparotomy.

The main objective of this study is to compare the influence of analgesic technique on the Quality of Recovery-15 score. The study design was a prospective, randomized trial with 2 parallel arms (epidural analgesia vs bilateral rectus sheath block).

Eligibility

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

Study details

Laparotomy

NCT04985695

Centre Hospitalier RĂ©gional Metz-Thionville

27 January 2024

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