RecruitingNot ApplicableNCT04985695

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block

Sponsor

Centre Hospitalier Régional Metz-Thionville

Enrollment

110 participants

Start Date

Oct 11, 2021

Study Type

INTERVENTIONAL

Conditions

Laparotomy

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria7

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

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Interventions

DRUGEpidural analgesia

All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.

DRUGBilateral rectus sheath block

Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump

PROCEDURELaparotomy

A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy