Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy (QORRECTCATH)

Centre Hospitalier Régional Metz-Thionville

Status: Enrolling

Conditions: Laparotomy

Treatments: Drug: Bilateral rectus sheath block; Procedure: Laparotomy; Drug: Epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04985695

2021-01-CHRMT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Thoracic epidural anesthesia

Active Comparator group

Description:

Epidural analgesia during midline laparotomy

Treatment:

Drug: Epidural analgesia

Procedure: Laparotomy

Bilateral rectus sheath block

Experimental group

Description:

Bilateral rectus sheath block during midline laparotomy

Treatment:

Procedure: Laparotomy

Drug: Bilateral rectus sheath block