Clinical trial

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

Name

2021-01-CHRMT

Description

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.

Trial arms

Trial start

2021-10-11

Estimated PCD

2025-10-10

Trial end

2026-04-10

Status

Recruiting

Treatment

Epidural 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.

Arms:

Thoracic epidural anesthesia

Bilateral 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

Arms:

Bilateral rectus sheath block

Laparotomy

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

Arms:

Bilateral rectus sheath block, Thoracic epidural anesthesia

Size

110

Primary endpoint

Change in total QoR-15 score

Postoperative day 2

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}

Updated at

2023-12-26

1 organization

2 products

1 indication

Organization

Centre Hospitalier Régional Metz-Thionville

Product

Epidural analgesia

Indication

laparotomy

Product

Bilateral rectus sheath block