Hepatic Resection, Laparotomy
Conditions
Keywords
Laparotomy, Hepatic resection, continuous wound catheter analgesia, morphine, post operative recovery
Brief summary
Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver resection. But, opioids tend to be ineffective for pain that is associated with movement and have significant short-term side effects including nausea, vomiting, sedation, pruritus, constipation, urinary, retention, and respiratory depression, which are factors that often hinder a patient's recovery. Prospective randomized trials has found continuous wound catheter analgesia as an accepted alternative to IV morphine PCA. The researchers will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce morbidity and provide a better recovery.
Detailed description
This study is a prospective, double blind, randomized study. Subjects will be randomized using a computer-generated table of random numbers into 2 groups. The patients scheduled to undergo open liver resection will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B). The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (10-ml bolus followed by an infusion of 10 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a elastomeric pump (500ml), set to deliver a 10-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. The primary endpoint : the opioid-related symptom distress scale (SDS) will be performed at 48 hours after surgery. Secondary endpoints will be pain intensity on a visual analog scale at rest, and on coughing, morphine consumption, respiratory dysfunction, transit recovery and side effects at 48 hours, 5 days after surgery.
Interventions
DRUGwound infusion ropivacaine
Laparotomy Hepatic surgery : Bolu of 10 ml de ropivacaine 0,2% + infusion with elastomeric pump with ropivacaine 0,2% at a 10ml/h during 48 hours.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-III * Scheduled for open hepatic resection * Patients must be able to understand the IV morphine PCA * Written informed consent * Free from pain in preoperative period
Exclusion criteria
* Age \< 18 years * Severe hepatic * Renal impairment * Pregnancy or lactation * Allergy to one of the specific drugs under study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the opioid-related symptom distress scale (SDS) | 48 h postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragmatic function | 48 h, 5 days postoperatively and discharge | Sniff-test and Peak-flow |
| total morphine consumption | 48 h, 5 days postoperatively and discharge | — |
| Recovery after surgery | 48 h, 5 days postoperatively and discharge | It is defined as the time to first flatus and recovery of bowel activity after surgery |
Countries
France
Outcome results
None listed