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.
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
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
Parallel
Epidural analgesia
DrugAll 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.
Bilateral rectus sheath block
DrugBilateral 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
Laparotomy
Procedure/SurgeryA midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
Change in total QoR-15 score
The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).
Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery
The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).
Efficacy of postoperative analgesia
The efficacy of postoperative analgesia was compared between the two groups with the visual analog scale (VAS). The VAS intensity rating consisted of a 100-mm line with the end points no pain (0 mm) and worst pain (100 mm). Study participants were asked to evaluated with a mark on the line their current pain intensity. The difference between each postoperative treatment VAS score was compared.
Impact of arterial hypotension
The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy
Impact of orthostatic hypotension
The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery.
Click on the lead sponsor to view all of their trials.
