Abdominal Surgery by Laparotomy, Analgesia, Lidocaine Adverse Reaction, Thoracic Epidural Analgesia
Conditions
Keywords
Abdominal surgery by laparotomy, thoracic epidural analgesia, Analgesia, Lidocaine Adverse Reaction
Brief summary
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period. Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery. Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.
Interventions
OTHERBlood sample
Lidocaine blood sample 30 min before the end of the surgery Lidocaine blood sample at the end of the infusion lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA Ropivacaine blood sample 24h after the infusion of the TEA
DRUGLidocain
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end) The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.
DRUGropivacaine
Lidocaine will be injected during the anaesthetic induction and infused until the surgical closure (30 minutes before the end), then ropivacaine will be injected in the TEA at the same time and infused during 24h. The occurrence of adverse events will be monitor by a physical examination and blood samples of lidocainemia and ropivacainemia in the perioperative period.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Abdominal surgery by laparotomy
Exclusion criteria
* laparoscopic abdominal surgery, * TEA contraindication, * ropivacaine contraindication * intravenous lidocaine contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood lidocaine concentration (micrograms/ml) | 30 minutes before the end of surgery | Lidocaine blood sample will be performed 30 min before the end of the surgery |
| blood lidocaine concentration (micrograms/ml) | at the end of the surgery (assessed up to 2 hours) | lidocaine blood sample will be performed at the end of the infusion, |
| blood lidocaine and ropivacaine concentration (micrograms/ml) | at 2 hours | lidocaine and ropivacaine blood sample 2 h after the ropivacaine infusion of the TEA, |
| blood ropivacaine concentration (micrograms/ml) | at 24 hours | ropivacaine blood sample 24h after the infusion of the TEA |
Countries
France
Outcome results
None listed