NCT Number: NCT04985695
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.
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All sexes
Interventional
Not applicable
CHR Metz Thionville Hopital de Mercy, Metz, Moselle, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
Time frame: Postoperative day 2
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).
Time frame: Postoperative days 1, and 3
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).
Time frame: Day 0 and Postoperative days 1, 2, 3 and 30
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.
Time frame: Postoperative days 1, 2 and 3
The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy
Time frame: Postoperative days 1, 2 and 3
The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery.
Time frame: Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
The effect of analgesic technique on nausea and/or vomiting is calculated on the basis of the number of anti-vomiting prescribed.
Time frame: Postoperative days 1, 2 and 3
Number of postoperative complication in both groups
Time frame: at hospital discharge up to 30 days
Comparison of the length of stay between the two groups
Time frame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
Delay in hours to promotes normal digestive activity. The included the times to recovery the first bowel sounds, first anal exhaust and defecation.
Time frame: Day 0 and Postoperative days 1, 2 and 3
The quantity of morphine or equivalent administered during the 48 first hours in both groups
Time frame: at hospital discharge up to 30 days
The time during which the patients are taking recourse to postoperative urinary catheterization
Time frame: Postoperative days 1, 2 and 3
Compare the impact of postoperative analgesia in Walking distance (meter) within days following the operation
Time frame: Postoperative day 1
Number of Failure to delivery catheter in both techniques
Time frame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
Delay before the first raised in hours
Time frame: on day 0
Number of premature discontinuation of local anesthetics
Time frame: at hospital discharge up to 30 days and on postoperative day 30
Satisfaction questionnaire
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Régional Metz-Thionville
Other
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block
Acronym: QORRECTCATH
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