NCT04985695

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Laparotomy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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
PROCEDURE	Laparotomy	A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy

Timeline

• Start date: 2021-10-11
• Primary completion: 2028-10-10
• Completion: 2029-04-10
• First posted: 2021-08-02
• Last updated: 2025-12-16

Locations

2 sites across 1 country: France